- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05542875
Effects of Thrust Versus Non-Thrust Thoracic Manipulation on Mechanical Neck Pain.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Foundation University College of Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Both genders
- Age: 18-24 years
- Symptoms <30 days
- FABQPA score <12
- Increased upper thoracic spine kyphosis (visual estimate)
- CVA < 48 Degrees
Exclusion Criteria
- Symptoms distal to shoulder
- Aggravation of symptoms with looking up
- Radiating lower back pain
- Neurological deficit
- Previous surgery
- Spondylolisthesis
- Spinal stenosis
- Inflammatory disease
- Vertebrobasilar artery insufficiency
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A (Thrust Manipulation)
Participants will be randomly allocated to Group A which will recieve Thrust manipulation treatment in addition to standard treatment protocol.
Prone thoracic extension manipulation technique will be applied from T2 - T6 to participants for 4 sessions on alternate days
|
Prone thoracic extension manipulation technique will be applied from T2 - T6 to participants of Group A (Experimental group).
Intervention will be applied on alternate days with a total of 4 treatment sessions
Standard treatment protocol includes moist heat, TENS and Post isometric relaxation technique. Standard treatment will be given to both groups on every session. Standard treatment consists of: Superficial Moist Heat (Device): Superficial moist heat will me applied for 10 minutes on Upper Trapezius TENS (Device): TENS will be applied for 10 minutes at 80-100Hz, the electrodes will be placed at upper trapezius. Post-isometric Relaxation (procedure/surgery): 5-10 repetions of Post Isometric relaxation technique will be applied on various muscle groups which include Upper trapezius, levator scapulae, sternocleidomastoid and scalenes. |
|
Experimental: Group B (Non-Thrust Manipulation)
Participants will be randomly allocated to group B which, in addition to standard treatment protocol, will recieve Maitland grade III or IV manipulation from T1 to T6. Posterior to anterior glide over spinous process will be maintained for 30 seconds.
Participants will recieve 4 sessions on alternate days
|
Standard treatment protocol includes moist heat, TENS and Post isometric relaxation technique. Standard treatment will be given to both groups on every session. Standard treatment consists of: Superficial Moist Heat (Device): Superficial moist heat will me applied for 10 minutes on Upper Trapezius TENS (Device): TENS will be applied for 10 minutes at 80-100Hz, the electrodes will be placed at upper trapezius. Post-isometric Relaxation (procedure/surgery): 5-10 repetions of Post Isometric relaxation technique will be applied on various muscle groups which include Upper trapezius, levator scapulae, sternocleidomastoid and scalenes.
Maitland grade III or IV thoracic 0manipulation will be given to participants of Control group from T1 to T6. Posterior to anterior glide over spinous process will be maintained for 30 seconds.
Intervention will be applied on alternate days with a total of 4 treatment sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Craniovertebral Angle
Time Frame: 8 days
|
Craniovertebral Angle wll be measured using Goniometer.
CVA >48 is considered normal, CVA <48 is considered as Forward head posture.
Immovable arm of the goniometer will be placed at the C7 spinous process and the movable arm at the tragus of the ear making an angle between the two lines, normal of which is 49.9 and angle less than that is considered as abnormal.
Data will be collected directly from participants using Gomiometer before initiation of treatment and after 4th session.
|
8 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical Range of Motion
Time Frame: 8 days
|
Cervical Range of motion will be measured using bubble inclinometer.
Measurement will be taken before the initiation of treatment and after 4Th treatment session.
Increase in Cervical ROM will be considered a positive outcome.
|
8 days
|
|
Pain intensity
Time Frame: 8 days
|
Pain will be assessed using Numeric pain rating scale which comprises of 11 points where point (0) signifies no pain and point (10) signifies worst imaginable pain.
Measurement will be taken before the initiation of treatment and after 4Th treatment session.
Low score for the NPRS will be considered a positive outcome.
|
8 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Other Study ID Numbers
- FUI/CTR/2022/15
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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