- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05305703
Effectiveness of Soft Tissue Mobilization
March 22, 2022 updated by: Esha Khan, University of Lahore
Effectiveness of Soft Tissue Mobilization and Trigger Point Release vs. Stretching on Tension-type Headache in University Students
The aim of this study was to determine the effects of soft tissue mobilization and trigger point release verses stretching in tension-type headache among university students.
Two randomized groups of participants with tension type headache will be treated with combination therapy of soft tissue mobilization and trigger point release therapy after the application of hot-pack in experimental group while control group received stretching of cervical muscles after hot-pack application .Both, male and female patients meeting the inclusion criteria will be included.
Patients having malignancy and cervical tumor will be excluded.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
It was a Randomized Control Trial Study.
Study setting was Bashir Institute of Health sciences.
Inclusion Criteria was Age 18 to 25 year's students, with tension type headache and trigger point in neck muscles.
30 Subjects were randomly and equally allocated to experimental group (n=15) and control group (n=15) through toss and coin method.
Outcomes include cervical range of motions were measured by Goniometer and VAS for paini.e., used at baseline and at the final session for duration of 3 weeks.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Islamabad, Pakistan, 04403
- Nasir khan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 18-25 years.
- Both Male and Female gender
- Trigger points in neck muscles
Exclusion Criteria:
- Patients taking pharmacologicaldrugs.
- Presence of co morbidities.
- Malignancy/ Trauma in cervical region
- Skin infections or open wound in cervical region
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cervical muscles Stretching
Stretching is applied to the effected muscles in order to increase the muscle length and flexibility by breaking adhesions.
Stretching exercises considerably decrease neck pain and improve range of motion
|
Heating therapy for 10 minutes Passive stretching of neck muscles including Sub-occipital muscles, Trapezius upper boarder and Sternocleidomastoid muscle with 10 reps each
|
EXPERIMENTAL: Soft tissue mobilization with trigger point release.
Soft tissue mobilization increases skin temperature, a rise in skin temperature indicates increase blood flow of involved area, provide relaxation and reduce muscle tension.Trigger point therapy is consisting of rubbing and pressing on trigger points.Heavy pressure must be applied to release trigger, light pressure is not effective.
Pressure should be applied slowly and released slowly for best results and the pressure should be maintained until there is a change in pain
|
Heating therapy for 10 minutes Soft tissue mobilization for 8 minutes and trigger point release of sub-occiptal muscles with 5 repetitions each.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes from baseline in Visual Analogue Scale
Time Frame: baseline and 3 weeks
|
Reliability of Visual Analogue Scale for pain measurement
|
baseline and 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes from baseline in Goniometer
Time Frame: baseline and 3 weeks
|
Goniometry is commonly used in clinical practice for assessment of range of motion and treatment interventions.
It is used in patients who have insufficient range of motion due to muscletightness, joint stiffness.
|
baseline and 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nasir khan, DPT, Bashir Institute of Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2019
Primary Completion (ACTUAL)
July 30, 2019
Study Completion (ACTUAL)
August 30, 2019
Study Registration Dates
First Submitted
March 12, 2022
First Submitted That Met QC Criteria
March 22, 2022
First Posted (ACTUAL)
March 31, 2022
Study Record Updates
Last Update Posted (ACTUAL)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 22, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ECCR/ Ref No.: BI-14/DPT2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Tension-Type Headache
-
Lucia Trullenque EspallargasNot yet recruitingChronic Tension-Type Headache | Episodic Tension-Type HeadacheSpain
-
Grand Valley State UniversityMary Free Bed Rehabilitation HospitalCompletedHeadaches, TensionUnited States
-
Azidus BrasilUnknownTreatment of Episodic Tension HeadacheBrazil
-
University of ValenciaCompletedTension-type HeadacheSpain
-
Riphah International UniversityCompletedTension Type HeadachePakistan
-
University of ValenciaCompleted
-
GlaxoSmithKlineTerminatedHeadache, Tension-TypeUnited States
-
University of ValenciaCompletedTension-type HeadacheSpain
-
University of MinnesotaWithdrawnTension-type HeadacheUnited States
-
University of Colorado, DenverNational Center for Complementary and Integrative Health (NCCIH)CompletedTension-type HeadacheUnited States
Clinical Trials on cervical stretching
-
Goethe UniversityCompletedRandomized Controlled Trial | Fascia | Myofascial | StretchingGermany
-
Cairo UniversityCompletedChronic Non-Specific Neck PainEgypt
-
Riphah International UniversityCompletedCervical RadiculopathyPakistan
-
Maharishi Markendeswar University (Deemed to be...Completed
-
Universidad de ZaragozaRecruitingAsymptomatic ConditionSpain
-
National Taiwan University HospitalUnknown
-
Cairo UniversityCompletedAdhesive Capsulitis | Stretch | Physical NeglectEgypt
-
Tokat Gaziosmanpasa UniversityCompleted
-
Universidade Estadual do Norte do ParanáCompletedMuscle Strength | Muscle Strength DynamometerBrazil