- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00030004
Pilot Study of Spinal Manipulation for Chronic Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There has been growing recognition of the high frequency with which Americans utilize complementary and alternative health care providers and that annually about 10% of the population is treated by a chiropractor. While chiropractors employ several types of treatment, spinal manipulation is the most important and unique of these therapies. Over 90% of the spinal manipulations performed in the U.S. are done by chiropractors with most of the remainder performed by osteopathic physicians. The annual number of chiropractic visits in the U.S. has been estimated at approximately 100 per 100 person-years.
Spinal manipulation and chiropractic have been controversial at least partially due to a paucity of clinical scientific evidence of benefit. For example, reviews of the literature on randomized clinical trials (RCT's) of manipulative treatment for back pain have variably found evidence of benefit or insufficient evidence of benefit. A review of the existing clinical trials of spinal manipulation for neck pain concluded that most of the five existing RCT's were of relatively poor quality and that, despite some evidence for very short-term benefit, studies of higher quality will be needed in order to determine whether there is clinical benefit for this condition. This issue is important since neck pain is the second most common reason for presentation to chiropractors.
There are several difficulties in researching the effects of spinal manipulation. Most of the conditions that are treated (i.e., back and neck pain) do not have a well-defined pathophysiology. Therefore, it is not possible to study treatment by evaluating the effects of treatment on physiological variables. The lack of a proven pathophysiology also leads to heterogeneous study populations with large variability in response to treatment. This makes it necessary to use large experimental populations in order to detect any effects of treatment. There is heavy reliance on subjective outcome measures in neck and back pain research, making these clinical trials particularly sensitive to placebo or "nonspecific" effects. The use of blinded subjects is the accepted method of dealing with these issues, but blinding is particularly difficult to achieve when investigating physical interventions, particularly those where the therapist can't be blinded as to whether s/he is delivering an actual or sham treatment.
The present proposal is in response to a request for applications for pilot studies to establish the methodological feasibility and strengthen the scientific rationale for proceeding to full-scale RCTs on the use of chiropractic or osteopathy to manage or treat musculoskeletal injuries and disorders. One of the stated goals of this request for applications is to refine the control strategy for studies of manipulative therapy. The proposed study will examine whether an amnestic agent, midazolam, can be used to blind subjects to their experimental group in a double-blind, pilot RCT. This proposal is similar to a study by Sloop et al who used diazepam to produce amnesia in a study of spinal manipulation for chronic neck pain. The present study will utilize an agent with more specific amnestic effects and will also address several methodological problems with their study. If successful, the methods employed in this pilot study may permit a high degree of blinding in full scale RCT's of spinal manipulation.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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New Hampshire
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Lebanon, New Hampshire, United States, 03766
- Dartmouth-Hitchcock Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Neck Pain
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Midazolam
Other Study ID Numbers
- R01AT000121-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neck Pain
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Riphah International UniversityCompletedCervical Pain | Mechanical Neck PainPakistan
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Riphah International UniversityCompleted
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Instituto Brasileiro de OsteopatiaCompletedNeck Pain | Pain, NeckBrazil
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Ankara UniversityCompleted
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Josue Fernandez CarneroCentro Universitario La SalleCompleted
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Sakarya UniversityUnknown
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Shanghai University of Traditional Chinese MedicineBeijing Hospital; Dongzhimen Hospital, Beijing; Traditional Chinese Medicine... and other collaboratorsNot yet recruiting
Clinical Trials on spinal manipulation
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University of FloridaCompleted
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University of Kansas Medical CenterNational Chiropractic Mutual Insurance Company FoundationCompleted
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Université du Québec à Trois-RivièresFoundation for Chiropractic Education and Research (FCER)Completed
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University of Western StatesNational Center for Complementary and Integrative Health (NCCIH)Completed
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Ignacio Alejandro Astudillo GanoraCompletedBack Pain | Lumbar Pain Syndrome | Back Pain, LowSpain
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Palmer College of ChiropracticCompleted
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Université Catholique de LouvainTerminated
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Grant SandersCompletedSubluxation of Joint of Lumbar Spine
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Universidade Federal de Sao CarlosFundação de Amparo à Pesquisa do Estado de São PauloCompletedShoulder Impingement SyndromeBrazil
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University of BrasiliaCompleted