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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT007311-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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Eligible subjects with chronic neck pain will be randomly allocated to one of two intervention groups: real vs control spinal manipulation. They will receive three intervention sessions.
H1: Chronic neck pain patients treated longitudinally over a series of three encounters in one week by random assignment to treatment group with either of the dual delivery procedures (Intervention 1=typical-control or Intervention 2=control-control) will have a 50% error rate of self-report of group allocation at exit interview.
H2: Patients treated by the typical-control dual procedure over a typical sequence of encounters (3 times in one week) will show statistically significant improvement in clinical outcomes; defined quantitatively by visual analogue pain scale (VAS), Neck Disability Index (NDI), range of motion and pressure algometry; compared to those treated by the control-control dual procedure.
H3: Patients stratified by 'a priori' patient expectation for treatment outcome will show no significant difference in self-report of group allocation or clinical outcome measures.
A total of 372 subjects will be recruited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal manipulation | Experimental | Participants will receive spinal manipulation delivered as segmental thrust to a specific site in the neck. They will receive three intervention sessions over 7-10 days. |
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| Control manipulation | Sham Comparator | Participants will receive spinal manipulation delivered as non-segmental thrust to the neck. They will receive three intervention sessions over 7-10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal manipulation | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Group registration | Participants will be asked to identify which of the two interventions they feel they received. | At exit assessment following the third intervention session |
| Measure | Description | Time Frame |
|---|---|---|
| Pain severity | Pain scores on the PROMIS pain severity instrument. | 1. at baseline, and 2. At exit assessment following the third intervention session |
| Improvement | Participants will be asked to rate their level of improvement on the The Global Rating of Change instrument. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety | All adverse events will be described and tallied. Adverse events will be categorized in two modes: 1] Serious vs. Not Serious, and, 2] Attributable to the trial vs. Not Attributable. Both the absolute number of adverse events as well as the percentage of subjects experiencing an adverse event will be reported. | Daily over 7-10 days. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howard T Vernon, DC, PhD | Canadian Memorial Chiropractic College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canadian Memorial Chiropractic College | Toronto | Ontario | M2H 3J1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16326235 | Result | Vernon H, MacAdam K, Marshall V, Pion M, Sadowska M. Validation of a sham manipulative procedure for the cervical spine for use in clinical trials. J Manipulative Physiol Ther. 2005 Nov-Dec;28(9):662-6. doi: 10.1016/j.jmpt.2005.07.020. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
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| ID | Term |
|---|---|
| D020393 | Manipulation, Spinal |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| At exit assessment following the third intervention session |
| Disability | Participants will score the The Neck Disability Index (score out of 50). | 1. at baseline, and 2. At exit assessment following the third intervention session |
| Tenderness | Pressure algometry over a single specified spinal site will be used to measure tenderness in kg/sq.sm. | 1. at baseline, and 2. At exit assessment following the third intervention session |
| Expectations related to improvement | Participants' expectations of the efficacy of the interventions will be obtained at baseline with the protocol of Fulda et al. | Baseline |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |