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Effectiveness of Soft Tissue Mobilization

Primary Purpose

Tension-Type Headache

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
cervical stretching
soft tissue mobilization
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tension-Type Headache

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nasir khan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cervical muscles Stretching

Soft tissue mobilization with trigger point release.

Arm Description

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

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

Outcomes

Primary Outcome Measures

changes from baseline in Visual Analogue Scale
Reliability of Visual Analogue Scale for pain measurement

Secondary Outcome Measures

changes from baseline in Goniometer
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.

Full Information

First Posted
March 12, 2022
Last Updated
March 22, 2022
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05305703
Brief Title
Effectiveness of Soft Tissue Mobilization
Official Title
Effectiveness of Soft Tissue Mobilization and Trigger Point Release vs. Stretching on Tension-type Headache in University Students
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-Type Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cervical muscles Stretching
Arm Type
Experimental
Arm Description
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
Arm Title
Soft tissue mobilization with trigger point release.
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
cervical stretching
Intervention Description
Heating therapy for 10 minutes Passive stretching of neck muscles including Sub-occipital muscles, Trapezius upper boarder and Sternocleidomastoid muscle with 10 reps each
Intervention Type
Other
Intervention Name(s)
soft tissue mobilization
Intervention Description
Heating therapy for 10 minutes Soft tissue mobilization for 8 minutes and trigger point release of sub-occiptal muscles with 5 repetitions each.
Primary Outcome Measure Information:
Title
changes from baseline in Visual Analogue Scale
Description
Reliability of Visual Analogue Scale for pain measurement
Time Frame
baseline and 3 weeks
Secondary Outcome Measure Information:
Title
changes from baseline in Goniometer
Description
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.
Time Frame
baseline and 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasir khan, DPT
Organizational Affiliation
Bashir Institute of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nasir khan
City
Islamabad
ZIP/Postal Code
04403
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Soft Tissue Mobilization

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