Pilot Study of Spinal Manipulation for Chronic Neck Pain

NCT00030004 | Terminated Phase 1

• 1 other identifier: R01AT000121-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to determine whether a medicine that can produce temporary amnesia (midazolam) can be used to block the memory of treatment with spinal manipulation. This is important since any study that is designed to determine whether spinal manipulation is effective would be better if patients were not aware of whether or not they were treated. This would allow a true assessment of treatment effects without the complication of a strong placebo effect that manipulative treatment may produce.

Conditions

Neck Pain

Interventions

spinal manipulation PROCEDURE

midazolam DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

This study will enroll patients with chronic neck pain (more than 3 months duration) with or without occipitally-based head pain and without signs of radiculopathy or myelopathy. They must have pain of at least moderate intensity (by their report and by a score of at least 3 out of 10 on a visual analogue pain scale) on at least four days out of a week and have had some limitations of activity on a weekly basis due to their neck pain. These subjects should not have had spinal manipulative treatment for at least two years and should not have had any adverse reactions to manipulative treatment or to benzodiazepines. They may not be regular users of benzodiazepine medications. They also should not be currently enrolled in an ongoing physical therapy program, though they may be taking analgesics, anti-inflammatories or other medications for their problem. They may continue with any ongoing exercise program. Subjects will also be excluded if they are pregnant, lactating or plan to be pregnant, if they have significant cardiac or pulmonary disease or if they plan on relocating during the course of the study. The subjects will also be evaluated by a trained and experienced manipulative practitioner (see below) for the presence of lesions which would be amenable to manipulation and by a medical physician for the absence of any contraindications to manipulative treatments.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Manipulation, Spinal; Midazolam

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 29, 2002
• First Posted: January 30, 2002
• Study Start: May 1, 2000
• Study Completion: April 1, 2001
• Last Updated: August 18, 2006

Record last verified: 2006-07

Locations

US (1)