Tension-Type HeadacheNCT05305703
Effectiveness of Soft Tissue Mobilization
A study testing cervical stretching and soft tissue mobilization in people with Tension-Type Headache, run by University of Lahore at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- cervical stretching and soft tissue mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2019to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-25 years.
- Both Male and Female gender
- Trigger points in neck muscles
Who cannot join
- Patients taking pharmacologicaldrugs.
- Presence of co morbidities.
- Malignancy/ Trauma in cervical region
- Skin infections or open wound in cervical region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tension-Type Headache
- Being tested
- cervical stretching, soft tissue mobilization
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical stretchingOther
Heating therapy for 10 minutes Passive stretching of neck muscles including Sub-occipital muscles, Trapezius upper boarder and Sternocleidomastoid muscle with 10 reps each
soft tissue mobilizationOther
Heating therapy for 10 minutes Soft tissue mobilization for 8 minutes and trigger point release of sub-occiptal muscles with 5 repetitions each.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: soft tissue mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes from baseline in Visual Analogue Scale
Reliability of Visual Analogue Scale for pain measurement
Measured: baseline and 3 weeks
Secondary outcomes (1)
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.
Measured: baseline and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Mar 2019
- Primary completion30 Jul 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esha Khan, University of Lahore
- Investigators
- Nasir khan, DPT, Principal investigator, Bashir Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305703
- Sponsor's protocol ID
- ECCR/ Ref No.: BI-14/DPT2019
- Status last verified
- Mar 2022
- First submitted
- 12 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Soft Tissue Mobilization and Trigger Point Release vs. Stretching on Tension-type Headache in University Students
- ClinicalTrials.gov ID
- NCT05305703
- Acronym / sponsor ID
- ECCR/ Ref No.: BI-14/DPT2019
- Conditions
- Tension-Type Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Cervical muscles Stretching | Experimental | Other: cervical stretchingStretching 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 with trigger point release. | Experimental | Other: soft tissue mobilizationSoft 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 |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18-25 years.
- Both Male and Female gender
- Trigger points in neck muscles
Key exclusion criteria (4 listed)
- Patients taking pharmacologicaldrugs.
- Presence of co morbidities.
- Malignancy/ Trauma in cervical region
- Skin infections or open wound in cervical region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical stretchingHeating therapy for 10 minutes Passive stretching of neck muscles including Sub-occipital muscles, Trapezius upper boarder and Sternocleidomastoid muscle with 10 reps each | Other | Cervical muscles Stretching |
| soft tissue mobilizationHeating therapy for 10 minutes Soft tissue mobilization for 8 minutes and trigger point release of sub-occiptal muscles with 5 repetitions each. | Other | Soft tissue mobilization with trigger point release. |
Primary outcome
changes from baseline in Visual Analogue Scale
Time frame: baseline and 3 weeks
Reliability of Visual Analogue Scale for pain measurement
1 secondary outcome
changes from baseline in Goniometer
Time frame: baseline and 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasir khan, DPT principal investigator
Bashir Institute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical stretching and soft tissue mobilization in people with Tension-Type Headache, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes from baseline in Visual Analogue Scale (time frame: baseline and 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022; AzTrials last refreshed its copy on 30 Oct 2026.