NCT05305703

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

March 12, 2022

Last Update Submit

March 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • changes from baseline in Visual Analogue Scale

    Reliability of Visual Analogue Scale for pain measurement

    baseline and 3 weeks

Secondary Outcomes (1)

  • changes from baseline in Goniometer

    baseline and 3 weeks

Study Arms (2)

Cervical muscles Stretching

EXPERIMENTAL

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

Other: cervical stretching

Soft tissue mobilization with trigger point release.

EXPERIMENTAL

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

Other: soft tissue mobilization

Interventions

Heating therapy for 10 minutes Passive stretching of neck muscles including Sub-occipital muscles, Trapezius upper boarder and Sternocleidomastoid muscle with 10 reps each

Cervical muscles Stretching

Heating therapy for 10 minutes Soft tissue mobilization for 8 minutes and trigger point release of sub-occiptal muscles with 5 repetitions each.

Soft tissue mobilization with trigger point release.

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-25 years.
  • Both Male and Female gender
  • Trigger points in neck muscles

You may not qualify if:

  • Patients taking pharmacologicaldrugs.
  • Presence of co morbidities.
  • Malignancy/ Trauma in cervical region
  • Skin infections or open wound in cervical region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nasir khan

Islamabad, 04403, Pakistan

Location

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Nasir khan, DPT

    Bashir Institute of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

March 12, 2022

First Posted

March 31, 2022

Study Start

March 1, 2019

Primary Completion

July 30, 2019

Study Completion

August 30, 2019

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations