Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
The Effectiveness of Thoracic Spine Manipulation on Pain and Disability in Patients with Neck Pain: A Pilot Randomized Clinical Trial.
Shamsuddin Khoja, Samannaaz, Daliman, Daniel, Regina Sara, Piva
Mechanical neck pain is generally treated with a multimodal neck program (MNP) that includes electro/thermal modalities, active exercises and some form of manual therapy (commonly non thrust) directed at the cervical spine. Recent studies reported beneficial effects of using Thoracic Thrust Manipulation (TTM) to treat mechanical neck pain. The aim of this pilot study was to compare the effects of a MNP and the same MNP supplemented by TTM on neck pain and disability, and to gather preliminary data to calculate sample size for future larger studies.
Subjects were randomized to receive MNP only or MNP +TTM for a maximum of 12 sessions 2x/week. Primary outcomes were 11-point numeric pain rating scale (NPS), Neck Disability Index (NDI), and a 15-point Global Rating of Change (GRC) to measure perceived change in health status. Neck active range of motion (AROM) was secondary outcome. Outcomes were collected at baseline, 2, 4, and 6 weeks (GRC was not collected at baseline). As the goal of the study was parameter estimate, hypotheses testing were not done. We determined clinically important changes by comparing the point estimates of within-patient changes for NPS and NDI to their established minimal clinical important differences (MCIDs). MCIDs for the NPS and NDI are 2 points and 10% change respectively. We calculated the percentage of subjects in each group who reported a moderate or higher improvement in the GRC at each follow-up. For neck AROM, changes greater than the published values of minimal detectable change (MDC) were considered a noticeable change. The between-groups differences at 6 weeks in primary outcomes were used to estimate sample size.
Twenty two subjects were randomized (68% female, mean age 38.2±10.7 yrs). Characteristics of both groups were similar at baseline. Both groups showed clinically important changes at 6 weeks on all primary outcome measures. Clinically important changes on the NDI were observed for the MNP+TTM group at 4 weeks as well. The only improvement in neck AROM was observed for right side rotation in the MNP+TTM group at 6 weeks. Compliance with intervention was similar in both groups. The difference between the two groups was very small for all outcomes (Figure). Results of sample size indicated that to have 80% power, a of.05, we would require over 150 subjects per group for pain and NDI, and over one thousand subjects per group for the GRC, which do not seem feasible.
Figure. Pain, disability, and perceived change in health status across time for primary outcomes. Dashed lines represent NMP+TTM, and solid lines represent MNP group. Error bars show 95% CI around the means.
Adding TTM to MNP seemed to accelerate improvement on the NDI, but no additional benefits were observed on pain, perceived change in health status, or AROM at 6 weeks. It may not be beneficial to supplement MNP with TTM while treating mechanical neck pain. Results suggest it may not be worth to allocate additional resources to pursue the same research question in a larger randomized trial. Communication of these preliminary data may prevent unworthy research expenses.
To cite this abstract, please use the following information:
Shamsuddin Khoja, Samannaaz, Daliman, Daniel, Regina Sara, Piva; The Effectiveness of Thoracic Spine Manipulation on Pain and Disability in Patients with Neck Pain: A Pilot Randomized Clinical Trial. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :2060