- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07134062
- Original Trial
The Effect of the Bridge Technique Mobilization With Movement Versus Trapezius Dry Needling in the Management of Cervical Dysfunction
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Palestine
-
Betlehem, Palestine, Palestinian Territory, occupied, p150
- Al Quds University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients aged (25 - 65) years, males & females.
- Cervical dysfunction
- Orthopedic dysfunction without neurological defects
- Limitation in ROM (extension & rotation)
- VAS scale scores for neck pain must be > 4/10
- Neck pain aggravated by neck posture or movement
- Willing to give an informed consent
Exclusion Criteria:
- Any known medical condition, cardio, cancer
- Manipulative treatment within the past three months
- Previous spinal surgery in the past five years
- Current use of medication
- Disc prolapse acute stage
- previous epidural injection since the onset of present symptoms
- diagnosis of any generalized neurological disorder
- medical red flags suggestive of severe pathology
- pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1 Bridge technique mobilization with movement
Patient in supine, head resting on a pillow, cervical spine relaxed in a neutral position, physiotherapist sitting or standing at the head of the table.
Hands support both sides of the head through the thenar eminence on each side, fingers in contact with the C7, T1or T2 articular pillar bilaterally
|
Patient in supine, head resting on a pillow, cervical spine relaxed in a neutral position, physiotherapist sitting or standing at the head of the table.
Hands support both sides of the head through the thenar eminence on each side, fingers in contact with the C7, T1or T2 articular pillar bilaterally.
|
|
Active Comparator: Group 2 Dry Needling
Participants in this group received two sessions per week of D.N. treatment for the trapezius muscle.
|
Participants in this group received two sessions per week of D.N. treatment for the trapezius muscle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Visual analogue scale (VAS)
Time Frame: pre and 1 day post treatment
|
Is the most commonly used method for assessing pain intensity.
The leftmost value on the 10-cm horizontal line used for VAS indicates a painless condition represented by 0. The rightmost value is 10, which represents extreme pain.
The subjects rated their feelings of pain on the line by themselves, thereby quantifying the pain.
The validity and reliability are very high.
|
pre and 1 day post treatment
|
|
Quality of life Questionnaire (QoL)
Time Frame: pre and 1 day post treatment
|
Is an instrument for measuring the Quality of an individual's life across a broad range of specific areas. Quality of life (QoL) could be viewed as a subjective, multidimensional concept that emphasizes an individual's current state's self-perception. However, the general Quality of life includes individuals' evaluation of all aspects of life, including the safety of the environment in which they live, whether they feel they have access to health care and social services, and their current spiritual status |
pre and 1 day post treatment
|
|
The Northwick Park Neck Pain Questionnaire (NPQ)
Time Frame: pre and 1 day post treatment
|
Measures neck pain and consequent patient disabilities.
It is easy to complete, to score, and it gives an objective measure to assess the monitor symptoms and outcome in patients with acute or chronic neck pain over time.
|
pre and 1 day post treatment
|
|
Neck Disability Index (NDI)
Time Frame: pre and 1 day post treatment
|
The Neck Disability Index (NDI) was grown in (1989) by Howard Vernon.
The Index developed to modify the Oswestry Low Back Pain Disability Index with the original author's permission J. Fairbank, (1980).
Vernon and Mior at (1991) the reliability and validity analysis finding have been published in the Manipulative and Physiologic Therapeutics Journal.
|
pre and 1 day post treatment
|
Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- 117/REC/2020
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
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