- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07324811
Effectiveness of a Home-based Cervical Motor Control Exercise Programme Versus Conventional Manual Therapy in Patients With Post-whiplash Neck Pain.
Effectiveness of a Home-based Cervical Motor Control Exercise Programme Versus Conventional Manual Therapy in Patients With Post-whiplash Neck Pain: a Randomised Clinical Trial.
Whiplash-associated disorders are a common cause of persistent neck pain following traffic accidents and are frequently associated with impairments in cervical motor control, pain, and functional disability. Therapeutic exercise aimed at restoring cervical motor control has shown promising results; however, evidence regarding the effectiveness of structured home-based exercise programs compared with conventional physiotherapy remains limited. The aim of this study was to compare the effectiveness of a home-based cervical motor control exercise program versus conventional physiotherapy in patients with whiplash-associated neck pain.
A randomized controlled trial with two parallel groups was conducted. Patients diagnosed with whiplash-associated neck pain were randomly assigned to either an experimental group performing a structured home-based cervical motor control exercise program or a control group receiving conventional physiotherapy based on manual therapy and cervical mobilization techniques. Outcome measures included pain intensity assessed using the Visual Analogue Scale, functional disability measured with the Neck Disability Index, and active cervical range of motion. Assessments were performed at baseline and after an eight-week intervention period.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Salamanca, Spain, 37002
- Universidad Pontificia de Salamanca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who met the following criteria were included:
- Age between 18 and 65 years.
- Clinical diagnosis of post-whiplash neck pain resulting from a traffic accident.
- Symptoms lasting longer than four weeks.
- Presence of neck pain with a minimum intensity of 3 points on the Visual Analogue Scale.
- Ability to understand and follow the instructions of the home exercise programme.
- Signed informed consent.
Exclusion Criteria:
- Patients with the following conditions were excluded:
- Signs of severe neurological compromise or significant structural cervical pathology (fractures, cervical instability, myelopathy).
- History of cervical surgery.
- Rheumatic, neurological, or systemic diseases that could influence the results.
- Previous physiotherapy treatment for the same episode in the three months prior to the study.
- Pregnancy or any medical contraindication for therapeutic exercise.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: home-based cervical motor control exercise programme
home-based cervical motor control exercise programme monitored by physiotherapists
|
home-based programme of active cervical motor control exercises supervised by physiotherapists
|
|
Active Comparator: conventional physiotherapy treatment
Conventional physiotherapy treatment including passive therapies (manual therapy) in the physiotherapy clinic.
|
Conventional physiotherapy treatment with passive therapy (manual therapy) carried out in a physiotherapy clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain
Time Frame: 2 months
|
measured using the visual analogue pain scale (VAS) (where 0 is the least possible pain and 10 is the maximum possible pain)
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
range of motion
Time Frame: 2 months
|
The range of active cervical movement was assessed using goniometry, recording the movements of flexion, extension, rotation, and lateralisation of the cervical spine.
|
2 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Randlov A, Ostergaard M, Manniche C, Kryger P, Jordan A, Heegaard S, Holm B. Intensive dynamic training for females with chronic neck/shoulder pain. A randomized controlled trial. Clin Rehabil. 1998 Jun;12(3):200-10. doi: 10.1191/026921598666881319.
- Jordan A, Bendix T, Nielsen H, Hansen FR, Host D, Winkel A. Intensive training, physiotherapy, or manipulation for patients with chronic neck pain. A prospective, single-blinded, randomized clinical trial. Spine (Phila Pa 1976). 1998 Feb 1;23(3):311-8; discussion 319. doi: 10.1097/00007632-199802010-00005.
- Bronfort G, Evans R, Nelson B, Aker PD, Goldsmith CH, Vernon H. A randomized clinical trial of exercise and spinal manipulation for patients with chronic neck pain. Spine (Phila Pa 1976). 2001 Apr 1;26(7):788-97; discussion 798-9. doi: 10.1097/00007632-200104010-00020.
- Kjellman GV, Skargren EI, Oberg BE. A critical analysis of randomised clinical trials on neck pain and treatment efficacy. A review of the literature. Scand J Rehabil Med. 1999 Sep;31(3):139-52. doi: 10.1080/003655099444489.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Neurologic Manifestations
- Wounds and Injuries
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Uterine Diseases
- Genital Diseases, Female
- Neck Injuries
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Pain
- Uterine Cervical Diseases
- Whiplash Injuries
- Motor Activity
Other Study ID Numbers
- 00043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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