A feasibility study assessing manual therapies to different regions of the spine for patients with subacute or chronic neck pain

doi:10.1016/j.jcme.2007.10.004

Journal of Chiropractic Medicine

Volume 7, Issue 1, March 2008, Pages 1-8

https://doi.org/10.1016/j.jcme.2007.10.004 Get rights and content

Abstract

Objective

The purpose of this project was to develop and test protocols for a randomized clinical trial of a combined therapeutic approach (thoracic spine and sacroiliac joint high-velocity, low-amplitude spinal manipulation [HVLA SM] + cervical spine postisometric relaxation) and cervical spine HVLA SM for patients with subacute or chronic neck pain.

Methods

Patients were recruited in the Quad Cities in Iowa and Illinois. After a baseline assessment visit, eligible patients were randomly assigned to cervical spine HVLA SM or to the combined therapeutic approach for 4 treatment visits over 2 weeks. Outcome assessments included the Neck Disability Index, visual analog scale, and posttreatment response questionnaire. Patient outcomes were not aggregated or compared by treatment group.

Results

It took approximately 8 months of planning, which included the development of forms and protocols, pretesting the forms, and training staff and clinicians in the standardized protocols. Twelve participants were screened, and 6 patients were enrolled and randomly allocated to care over a 6-week period. All patients completed 5 visits. Five of 6 patients had an improvement on the Neck Disability Index. On the visual analog scale, 2 patients improved at 2 weeks, whereas the other 4 got worse. Five patients completed the posttreatment response questionnaire; 2 of the 5 indicated they experienced discomfort or an unpleasant reaction from the study treatments.

Conclusions

Designing a successful feasibility randomized clinical trial requires considerable planning, development and pretesting of the forms and protocols, and training clinicians and staff for standardized protocols. Patients were willing to be randomized, follow treatment protocols, complete baseline and outcome assessments, and return 83% of the follow-up questionnaires.

Introduction

Neck pain is a common musculoskeletal problem affecting up to 30% of adults in a given year.1, 2 Similar to low back pain, neck pain can be a chronic and disabling problem. Up to 5% to 10% of adults will be disabled with chronic neck pain.1, 2 Presently, there is no conclusive evidence for the effectiveness of high-velocity, low-amplitude spinal manipulation (HVLA SM) or other conservative manual therapy techniques for patients with acute, subacute, or chronic neck pain. A systematic review of the effectiveness of HVLA SM and mobilization for mechanical neck disorders revealed that HVLA SM and/or mobilization when done alone was not beneficial and that, when compared with one another, neither was superior.³

High-velocity, low-amplitude spinal manipulation is commonly used by manual therapists and doctors of chiropractic to treat spinal pain; but it is also commonly associated with minor transient adverse reactions such as local pain and stiffness, fatigue, or headaches. Observational studies have investigated the frequency and percentage of patients who experience these minor transient adverse reactions. A prospective, clinic-based survey of 102 Norwegian chiropractors reported that at least one minor adverse reaction was reported by 55% of the patients some time during the course of a maximum of 6 treatment visits.⁴ Studies from Sweden and Great Britain reported similar percentages of patients with minor adverse reactions.5, 6 Recent randomized clinical trials (RCTs) of patients with neck pain have also reported minor adverse reactions in which HVLA SM and other manual therapies were used as the primary interventions.7, 8 The frequencies reported in these RCTs ranged from 9% to 28% for the most common reaction, increased neck pain.

There is preliminary evidence that HVLA SM to the thoracic spine and muscle energy technique(s) to the cervical musculature may be helpful for neck pain. Cassidy et al9, 10 found that there was no statistically significant difference in patients with neck pain between HVLA SM and a muscle energy technique in terms of pain intensity. Both treatment groups demonstrated decreased pain immediately after treatment. However, only one treatment was performed; and there was no follow-up assessment beyond immediate effects. In another study, it was found that thoracic spine HVLA SM reduced neck pain more than a sham thoracic HVLA SM when measured immediately after treatment.¹¹ The results were statistically significant; but because the sample size was small and only immediate effects were measured, the results need to be interpreted with caution. We believe that there is potential for muscle energy techniques and thoracic spine HVLA SM for relieving neck pain.

Although there are no published clinical studies that suggest sacroiliac HVLA SM is helpful for neck pain, there is anecdotal evidence to suggest that a biomechanical relationship exists between the spinal regions caudal to the cervical spine and the cervical spine.12, 13 Because of the scarcity of studies investigating the muscle energy technique—postisometric relaxation (PIR), and thoracic and sacroiliac HVLA SM for neck pain—this study looked at a combined therapeutic approach using thoracic spine and sacroiliac HVLA SM and PIR in patients with subacute or chronic neck pain. A long-term goal is to identify specific types of combined therapeutic approaches that are most effective in reducing neck pain and disability and that result in a low percentage of minor, transient adverse reactions.

Because RCTs are expensive and involve human participants, feasibility studies are recommended to test a study's protocols. Feasibility studies are especially important for new investigators and for investigators who are recruiting participants in a particular geographic area for the first time. The purpose of this study was to develop and test protocols for an RCT of a combined therapeutic approach and cervical spine HVLA SM for patients with subacute or chronic neck pain. Protocols tested included patient recruitment, telephone and face-to-face screening interviews, informed consent, physical examination, enrollment, and treatment procedures for HVLA SM as well as for the PIR technique to the cervical spine musculature.

Section snippets

Methods

It took approximately 7 months to design and pretest the study protocols and forms. An additional 3 weeks was needed to train 4 research staff and 2 clinicians for eligibility screening protocols, patient flow and administration of self-report questionnaires, and examination and treatment protocols. All members of the study team were trained with standardized protocols before patient recruitment.

Our target enrollment for this project was 6 patients with subacute or chronic neck pain. Patients

Results

Pretesting the forms before the study began was valuable to ensure the items and patient instructions were clear and understandable and to minimize missing data from participants. The baseline assessment forms went through 2 rounds of iterative feedback before recruitment began.

Twelve individuals were recruited from a classified newspaper ad (n = 4), a list of ineligible participants from an ongoing low back study (n = 5), and by word of mouth/study flier (n = 3). Of these, 5 were ineligible

Discussion

Recruitment, enrollment, and follow-up of patients were completed over 10 weeks; and as a result, the duration of the treatment schedule was short and the sample size was small. Although the duration of treatment schedule and sample size were feasible for the purposes of completing the project during a master's program, the patient-related data reported in the results must be interpreted with caution. A sample size of 6 patients is not large enough for any type of formal statistical testing of

Conclusion

Designing even a small RCT is challenging and involves many personnel. Careful planning and teamwork are essential for the design and successful conduct of an RCT. The study protocols and forms used in this project were efficient, collected comprehensive data, and allowed us to reach our goals. This study provided us with valuable experience in the conduct of a feasibility study of an RCT. The integrity of clinical trials is dependent on methods or protocols. It is more advantageous to spend

Acknowledgment

The authors would like to thank the following people for making this study successful: Drs Cynthia Long and Dana Lawrence for assisting in the design and serving on the advisory committee for the first author, Dr Robert Rowell for assisting in the development of forms and protocols and serving as a clinician, Dr Steve Rylander for being a study clinician, Therese Devlin, Tammi White, Lori Byrd, and Dr Andrea Haan for assisting in the implementation of the study and the recruitment of

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Cited by (18)

Predictive factors for reporting adverse events following spinal manipulation in randomized clinical trials – secondary analysis of a systematic review
2017, Musculoskeletal Science and Practice
While spinal manipulative therapy (SMT) is recommended for the treatment of spinal disorders, concerns exist about adverse events associated with the intervention. Adequate reporting of adverse events in clinical trials would allow for more accurate estimations of incidence statistics through meta-analysis. However, it is not currently known if there are factors influencing adverse events reporting following SMT in randomized clinical trials (RCTs). Thus our objective was to investigate predictive factors for the reporting of adverse events in published RCTs involving SMT. The Physiotherapy Evidence Database (PEDro) and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for RCTs involving SMT. Domains of interest included: sample size; publication date relative to the 2010 CONSORT statement; risk of bias; the region treated; and number of intervention sessions. 7398 records were identified, of which 368 articles were eligible for inclusion. A total of 140 (38.0%) articles reported on adverse events. Articles were more likely to report on adverse events if they possessed larger sample sizes, were published after the 2010 CONSORT statement, had a low risk of bias and involved multiple intervention sessions. The region treated was not a significant predictor for reporting on adverse events. Predictors for reporting on adverse events included larger sample size, publication after the 2010 CONSORT statement, low risk of bias and trials involving multiple intervention sessions. We recommend that researchers focus on developing robust methodologies and participant follow-up regimens for RCTs involving SMT.
The risk of bias and sample size of trials of spinal manipulative therapy for low back and neck pain: Analysis and recommendations
2014, Journal of Manipulative and Physiological Therapeutics
The purpose of this study was to evaluate changes in methodological quality and sample size in randomized controlled trials (RCTs) of spinal manipulative therapy (SMT) for neck and low back pain over a specified period. A secondary purpose was to make recommendations for improvement for future SMT trials based upon our findings.
Randomized controlled trials that examined the effect of SMT in adults with neck and/or low back pain and reported at least 1 patient-reported outcome measure were included. Studies were identified from recent Cochrane reviews of SMT, and an update of the literature was conducted (March 2013). Risk of bias was assessed using the 12-item criteria recommended by the Cochrane Back Review Group. In addition, sample size was examined. The relationship between the overall risk of bias and sample size over time was evaluated using regression analyses, and RCTs were grouped into periods (epochs) of approximately 5 years.
In total, 105 RCTs were included, of which 41 (39%) were considered to have a low risk of bias. There is significant improvement in the mean risk of bias over time (P < .05), which is the most profound for items related to selection bias and, to a lesser extent, attrition and selective outcome reporting bias. Furthermore, although there is no significant increase in sample size over time (overall P = .8), the proportion of studies that performed an a priori sample size calculation is increasing statistically (odds ratio, 2.1; confidence interval, 1.5-3.0). Sensitivity analyses suggest no appreciable difference between studies for neck or low back pain for risk of bias or sample size.
Methodological quality of RCTs of SMT for neck and low back pain is improving, whereas overall sample size has shown only small and nonsignificant increases. There is an increasing trend among studies to conduct sample size calculations, which relate to statistical power. Based upon these findings, 7 areas of improvement for future SMT trials are suggested.
Adverse events associated with the use of cervical manipulation and mobilization for the treatment of neck pain in adults: A systematic review
2010, Manual Therapy
Citation Excerpt :
The use of a continuity correction with the Mantel Hansel method for zero cell counts has been shown to be the least biased method (Sweeting et al., 2004). In the Strunk and Hondras, 2008 trial however, the small sample size is a significant limitation of this study. Caution must be used however as the GRADE of evidence of these two trials is low (Table 2).
Adverse events (AE) are a concern for practitioners utilizing cervical manipulation or mobilization. While efficacious, these techniques are associated with rare but serious adverse events. Five bibliographic databases (PubMed, CINAHL, PEDro, AMED, EMBASE) and the gray literature were searched from 1998 to 2009 for any AE associated with cervical manipulation or mobilization for neck pain. Randomized controlled trials (RCTs), prospective or cross-sectional observational studies were included. Two independent reviewers conducted study selection, method quality assessment and data abstraction. Pooled relative risks (RR) were calculated. Study quality was assessed using the Cochrane system, a modified Critical Appraisal Skills Program form and the McHarm scale to assess the reporting of harms. Seventeen of 76 identified citations resulted in no major AE. Two pooled estimates for minor AE found transient neurological symptoms [RR 1.96 (95% CI: 1.09–3.54) p < 0.05]; and increased neck pain [RR 1.23 (95% CI: 0.85–1.77) p > .05]. Forty-four studies (58%) were excluded for not reporting AE. No definitive conclusions can be made due to a small number of studies, weak association, moderate study quality, and notable ascertainment bias. Improved reporting of AE in manual therapy trials as recommended by the CONSORT statement extension on harms reporting is warranted.
Adverse events and manual therapy: A systematic review
2010, Manual Therapy
To explore the incidence and risk of adverse events with manual therapies.
The main health electronic databases, plus those specific to allied medicine and manual therapy, were searched. Our inclusion criteria were: manual therapies only; administered by regulated therapists; a clearly described intervention; adverse events reported. We performed a meta-analysis using incident estimates of proportions and random effects models.
Eight prospective cohort studies and 31 manual therapy RCTs were accepted. The incidence estimate of proportions for minor or moderate transient adverse events after manual therapy was ∼41% (CI 95% 17–68%) in the cohort studies and 22% (CI 95% 11.1–36.2%) in the RCTs; for major adverse events ∼0.13%. The pooled relative risk (RR) for experiencing adverse events with exercise, or with sham/passive/control interventions compared to manual therapy was similar, but for drug therapies greater (RR 0.05, CI 95% 0.01–0.20) and less with usual care (RR 1.91, CI 95% 1.39–2.64).
The risk of major adverse events with manual therapy is low, but around half manual therapy patients may experience minor to moderate adverse events after treatment. The relative risk of adverse events appears greater with drug therapy but less with usual care.
Manipulation or mobilisation for neck pain: A Cochrane Review
2010, Manual Therapy
Citation Excerpt :
one manipulation technique is not superior to another for pain reduction for subacute neck pain (three trials, 88 participants; Yurkiw and Mior, 1996; van Schalkwyk and Parkin-Smith, 2000; Wood et al., 2001); manipulation is equivalent to certain medication (2 trials, 69 participants; Sloop et al., 1982; Howe et al., 1983), acupuncture (2 trials, 81 participants; Giles and Muller, 1999; Muller and Giles, 2005), certain soft-tissue treatments (1 trial, 53 participants; Nilsson et al., 1997∗) or certain combined treatments for subacute and chronic neck pain and to some extent improved function (Strunk and Hondras, 2008); and manipulation may be superior to TENS (1 trial, 64 participants; Chen et al., 2007) for individuals with chronic cervicogenic headache.
Manipulation and mobilisation are often used, either alone or combined with other treatment approaches, to treat neck pain. This review assesses if manipulation or mobilisation improves pain, function/disability, patient satisfaction, quality of life (QoL), and global perceived effect (GPE) in adults experiencing neck pain with or without cervicogenic headache or radicular findings. A computerised search was performed in July 2009. Randomised trials investigating manipulation or mobilisation for neck pain were included. Two or more authors independently selected studies, abstracted data, and assessed methodological quality. Pooled relative risk (pRR) and standardised mean differences (pSMD) were calculated. 33% of 27 trials had a low risk of bias. Moderate quality evidence showed cervical manipulation and mobilisation produced similar effects on pain, function and patient satisfaction at intermediate-term follow-up. Low quality evidence suggested cervical manipulation may provide greater short-term pain relief than a control (pSMD −0.90 (95%CI: −1.78 to −0.02)). Low quality evidence also supported thoracic manipulation for pain reduction (NNT 7; 46.6% treatment advantage) and increased function (NNT 5; 40.6% treatment advantage) in acute pain and immediate pain reduction in chronic neck pain (NNT 5; 29% treatment advantage). Optimal technique and dose need to be determined.
What Are the Clinical Criteria Justifying Spinal Manipulative Therapy for Neck Pain?- A Systematic Review of Randomized Controlled Trials
2013, Pain Medicine (United States)
Citation Excerpt :
Four studies [37–40] used mobilization or manipulation but not both, whereas two studies [18,25] used a combination of these interventions. For six of the reports [17,20,27,37,41,42] it was not possible to determine if mobilization or manipulation was use alone or in combination. More than half (18/30) of the articles [12,16,19,21,23,25,27,29–31,34,36,37,39–43] did not provide any information in their introduction that explained why manipulation was used as the treatment.
Manipulation and mobilization are used to treat neck pain. However, little is known about the diagnostic criteria used to determine the need for manipulation in cases of neck pain. The primary aim of this study was to determine what diagnostic criteria are used to identify which neck pain sufferers should receive spinal manipulation or mobilization.
We systematically reviewed randomized controlled trials (RCT) involving mobilization or manipulation for neck pain. A data extraction pro forma was developed and trialled before two independent assessors extracted data sets from each RCT. A descriptive analysis was undertaken.
Thirty RCTs met the inclusion criteria. Acute and chronic “Mechanical” neck pain was the most common (43%) diagnosis at recruitment to the RCTs but some (10%) included patients with cervicogenic headache. Clinical criteria were used to determine the need for neck manipulation in over half (63%) of the RCTs. This usually involved exclusion of serious conditions, manual examination for tenderness on palpation, and/or altered vertebral motion in the neck or upper thoracic region which are known to lack validity. The remainder of the RCTs did not report a diagnostic strategy. All RCTs lacked detail descriptions of diagnostic criteria or interventions used.
This systematic review highlights the absence of reliable and valid diagnostic protocols to determine the need for spinal manipulation in persons presenting with non-serious, idiopathic, or whiplash-associated (grade II) neck pain. Guidelines requiring the reporting of valid diagnostic criteria are needed to improve the quality of RCTs concerning manual therapy.

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^☆: The authors declare that they have no competing interests. This study was supported in part by a grant from the National Institutes of Health (K30-AT-00977-04) and was conducted in a facility constructed with support from a Research Facilities Improvement Grant (C06 RR15433) from the National Center for Research Resources, National Institutes of Health.

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Original articleA feasibility study assessing manual therapies to different regions of the spine for patients with subacute or chronic neck pain☆

Abstract

Objective

Methods

Results

Conclusions

Introduction

Section snippets

Methods

Results

Discussion

Conclusion

Acknowledgment

Man Ther

The Saskatchewan Health and Back Pain Survey. The prevalence of neck pain and related disability in Saskatchewan adults

Spine

Neck pain in the general population

Spine

A Cochrane review of manipulation and mobilization for mechanical neck disorders

Spine

Frequency and characteristics of side effects of spinal manipulative therapy

Spine

Side effects of chiropractic treatment: a prospective study

J Manipulative Physiol Ther

Adverse effects of spinal manipulation

J R Soc Med

A randomized clinical trial of exercise and spinal manipulation for patients with chronic neck pain

Spine

Manual therapy, physical therapy, or continued care by a general practitioner for patients with neck pain. A randomized, controlled trial

Ann Intern Med

The immediate effect of manipulation versus mobilization on pain and range of motion in the cervical spine: a randomized controlled trial

J Manipulative Physiol Ther

Re: the immediate effect of manipulation vs. mobilization on pain and range of motion in the cervical spine: a randomized controlled trial (letter)

J Manipulative Physiol Ther

Original article
A feasibility study assessing manual therapies to different regions of the spine for patients with subacute or chronic neck pain☆