- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06751758
Suboccipital Distraction vs. Manual Traction in Chronic Neck Pain
Effects of Sub Occipital Distraction Versus Manual Traction on Upper Cervical Pain, Range of Motion and Functional Disability in Chronic Neck Pain
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 54782
- Neuro Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Minimum chronicity: of 3 months chronic neck pain (21)
- Spurling test (22)
Exclusion Criteria:
- Chronic systemic bony diseases
- Degenerative joint diseases
- Psychiatric diseases
- Recent history of trauma
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 |
|---|---|
|
Experimental: Group A - Suboccipital Distraction
In addition to the initial conservative treatment phase (cervical spine mobilization targeting the C1-C2 region and a 20-minute session of Transcutaneous Electrical Nerve Stimulation (TENS)), participants in Group A will undergo suboccipital distraction as part of the subsequent intervention.
Suboccipital distraction involves the gentle separation of the suboccipital muscles and associated structures to alleviate tension and promote relaxation.
This technique specifically targets upper cervical pain and aims to enhance range of motion.
|
Participants in both Group A and Group B will receive manual mobilization targeting the C1-C2 region.
This specific mobilization technique is chosen for its potential to improve joint mobility and alleviate stiffness in the upper cervical spine.
The mobilization will be performed by trained physiotherapists to ensure precision and safety.
Following C1-C2 mobilization, each participant will undergo a 20-minute session of TENS.
TENS involves the application of low-voltage electrical currents through electrodes placed on the skin.
This modality aims to modulate pain perception by stimulating nerve fibers, leading to the release of endorphins - the body's natural painkillers.
The 20-minute duration is chosen based on established guidelines for effective TENS application.
Suboccipital distraction is a manual technique aimed at relieving tension in the upper cervical spine. This intervention involves the gentle separation of the suboccipital muscles and associated structures, promoting relaxation and reducing pain. The technique is intended to enhance the range of motion in the cervical region by targeting the upper cervical structures. Procedure: 5-7 repetitions of intermittent distraction 20-30 seconds on, 10-15 seconds off Administration: Suboccipital distraction will be performed by skilled physiotherapists trained in this technique. Close monitoring will ensure correct application and participant safety. |
|
Active Comparator: Group B - Traction
After the initial conservative treatment phase (cervical spine mobilization targeting the C1-C2 region and a 20-minute session of Transcutaneous Electrical Nerve Stimulation (TENS)), participants in Group B will receive traction as their intervention.
Traction involves the application of controlled force to stretch and mobilize the cervical spine manually.
The aim is to reduce compression on cervical structures, alleviate pain, and improve the range of motion.
|
Participants in both Group A and Group B will receive manual mobilization targeting the C1-C2 region.
This specific mobilization technique is chosen for its potential to improve joint mobility and alleviate stiffness in the upper cervical spine.
The mobilization will be performed by trained physiotherapists to ensure precision and safety.
Following C1-C2 mobilization, each participant will undergo a 20-minute session of TENS.
TENS involves the application of low-voltage electrical currents through electrodes placed on the skin.
This modality aims to modulate pain perception by stimulating nerve fibers, leading to the release of endorphins - the body's natural painkillers.
The 20-minute duration is chosen based on established guidelines for effective TENS application.
Traction is a therapeutic technique that involves applying a controlled, manual force to stretch and mobilize the cervical spine. The primary goal of this intervention is to reduce compression on the cervical structures, alleviate pain, and improve the range of motion. It is typically used for its potential to decompress the spine and relieve pressure on nerves. Procedure: Traction will be administered manually by trained physiotherapists, who will ensure that the correct amount of force is applied and that the treatment is both safe and effective. The application will be carefully tailored to the individual's needs. Administration: Participants will undergo traction treatments with close monitoring throughout the study period, allowing for necessary adjustments to the treatment plan based on individual responses. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NPRS (Numerical Pain Rating Scale)
Time Frame: baseline, after 4 weeks
|
The NPRS is a self-report measure used to assess the intensity of pain experienced by individuals. Participants rate their pain on a numerical scale from 0 (no pain) to 10 (worst possible pain). It is known for its simplicity and ease of administration, making it a practical tool in clinical and research settings. Psychometric Properties: Validity: Strong convergent validity demonstrated in studies such as Jensen et al. (1986), which compared NPRS with other established pain measures. Reliability: The NPRS has been shown to have good test-retest reliability, with consistent pain ratings over time. Usefulness: Widely used in clinical settings due to its solid psychometric properties, making it valuable for assessing pain intensity in various populations. |
baseline, after 4 weeks
|
|
Goniometer
Time Frame: baseline, after 4 weeks
|
The goniometer is a fundamental tool for objectively measuring joint range of motion (ROM).
It consists of a protractor-like device that quantifies the angular displacement of a joint during movement.
Validity and reliability of goniometric measurements are crucial to ensure accurate and consistent assessments.
Previous research, such as the work by Norkin and White (2009), has supported the concurrent validity of goniometry by comparing its measurements with those obtained through radiographic imaging (25).
The goniometer's well-established validity and reliability make it an indispensable tool for assessing joint mobility and tracking changes in range of motion over time.
|
baseline, after 4 weeks
|
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NDI
Time Frame: baseline, after 4 weeks
|
This will be used to measure function of neck.Neck disability index was the first tool to measure the self-reported disability in patients with neck pain. It has significant psychometric features and has been shown to be very responsible in clinical trials. The index has 10 neck-related functional activities scored on a 0-5 likert scale for each item and total score of 50. Higher score on the scale shows greater disability. The NDI has very good reliability (ICC = 0.88;[0.63 to 0.95]) (26, 27). |
baseline, after 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Noor Fatima, DPT, Riphah International University, Lahore
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Noor Fatima
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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