Behavior, SocialNCT06086600
Instrument Assisted Soft Tissue Mobilization Versus Dynamic Oscillatory Stretch Technique in Females Wearing High Heels
A study testing Instrument Assisted Soft Tissue Mobilization and Dynamic oscillatory stretch technique in people with Behavior, Social, run by Riphah International University at 1 site in Pakistan.
Trial summary
Rationale of this research is to compare the effect of instrument assisted soft tissue mobilization and dynamic oscillatory stretch technique on gastro soleus muscles flexibility with shortened calf muscle-tendon unit (MTU),thicker and stiffer Achilles tendon in individual wearing high heel. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Behavior, Social
- What is being tested?
- Instrument Assisted Soft Tissue Mobilization and Dynamic oscillatory stretch technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Apr 2023to 15 Jan 2024
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-40 years
- Duration of wearing heels: minimum 1 year
- Wearing heels for minimum 3 times a week and 5 hours a day.
- Heel height: 2" and above
- Ankle Dorsiflexion ROM: decreased dorsiflexion (about 17 degrees)
- Pain scale showing more than 3.
Who cannot join
- DVT
- Musculoskeletal injury or surgery of lower limb.
- Acute Cardio-Respiratory or Neurological condition.
- Medical or surgical co-morbidities
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Gulberg green campus of Riphah International University
Islamabad, Punjab Province, 44000
Ramsha Tariq, MSOMPT, 03315251422, ramsha.tariq@riphah.edu.pk
mehr un nisa, MS-OMPT
About this study
Official title: Comparison of Instrument Assisted Soft Tissue Mobilization Versus Dynamic Oscillatory Stretch Technique in Females Wearing High Heels
Rationale of this research is to compare the effect of instrument assisted soft tissue mobilization and dynamic oscillatory stretch technique on gastro soleus muscles flexibility with shortened calf muscle-tendon unit (MTU),thicker and stiffer Achilles tendon in individual wearing high heel. This study will observe effect in all range of motion of ankle joint. In Pakistan no previous research is conducted, that compare the effect of IASTM and DOST in females wearing high heel.
Read the detailed description
Regular wearing of high heels would lead to shortening of the fascicles of the gastrocnemius muscle together with changes in the mechanical properties of the Achilles' Tendon, by the continuous ankle plantar flexion cause by the heel lift resulting in functional alteration. The purpose of the study is to identify the optimal technique for alleviating the symptoms in patients with high heel syndrome. It is a randomized controlled trial.Sample size is total 54 participants which would be divided into two groups, 27 each.Non-probability Convenience Sampling will be used and participants are randomly assigned into GROUP A(IASTM) and GROUP B (DOST) through sealed envelope methods after baseline assessment. All participants in both groups were evaluated on two occasions: (i) baseline (ii) at 12th session.
- Conditions
- Behavior, Social
- Being tested
- Instrument Assisted Soft Tissue Mobilization, Dynamic oscillatory stretch technique
- Keywords
- instrument assisted soft tissue mobilization, dynamic oscillatory stretch technique, high heel users
- Medical subject headings
- Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument Assisted Soft Tissue MobilizationOther
give gentle strokes from proximal to distal to check for trigger point or taut band. After knowing the exact location, give gentle strokes with minimal pressure in all directions by keeping the instrument in 30 to 60 degree angle. Application time will be between 40- 120 seconds.
Conventional treatment will include
- Hot pack for 10-15 min (calf muscles)
- Stretching exercises of gastro-soleus (10reps x 2Sets).
- Post session : Cold pack for 5 minutes (calf muscles)
Dynamic oscillatory stretch techniqueOther
Passively dorsiflexe the ankle to a point of the first stretch sensation. The next component to DOS, 2- second, passive stretch with slow oscillations at end range was applied. This procedure is repeated 10 times in each set with total of 3 sets .Therefore,10reps x2 second hold oscillation x 3 sets are given.Conventional treatment will include
- Hot pack for 10-15 min (calf muscles)
- Stretching exercises of gastro-soleus (10reps x 2Sets).
- Post session : Cold pack for 5 minutes (calf muscles
| Study group | Role | What they receive |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilization | Experimental | Graston tool on gastrocnemius and soleus muscle. Conventional treatment will include
* Hot pack for 10-15 min (calf muscles)
* Stretching exercises of gastro-soleus (10reps x 2Sets).
* Post session : Cold pack for 5 minutes (calf muscles) Receives: Other: Instrument Assisted Soft Tissue Mobilization |
| Dynamic oscillatory stretch technique | Active comparator | Dynamic oscillatory stretch technique on gastrocnemius and soleus muscle10reps x2 second hold oscillation x 3 sets.
Conventional treatment will include
* Hot pack for 10-15 min (calf muscles)
* Stretching exercises of gastro-soleus (10reps x 2 Sets).
* Post session : Cold pack for 5 minutes (calf Muscles Receives: Other: Dynamic oscillatory stretch technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle Range of Motion
Goniometer is used to measure ankle dorsiflexion, Plantarflexion, inversion, eversion ROM and it is use to assess and monitor patient's mobility to track progress during rehabilitation.
Measured: 4th week
Lower Extremity Functional Scale (LEFS)
The Lower Extremity Functional Scale (LEFS) is a commonly used tool in physical therapy and rehabilitation to assess the functional abilities of patients with lower extremity impairments. It is a self-reported questionnaire that consists of 20 items, each with five response options ranging from 0 (unable to perform) to 4 (able to perform without difficulty). The scores on the LEFS range from 0 to 80, with higher scores indicating better function.
Measured: 4th week
NUMERIC PAIN RATING SCALE
The numeric pain rating scale is used to measure pain intensity. It typically ranges from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain. Patients are asked to rate their pain on this scale, with the healthcare provider using the rating to help guide treatment decisions. It is a simple and effective way to communicate pain intensity, and can be useful in tracking changes in pain over time.
Measured: 4th week
Secondary outcomes (4)
ROM ankle dorsi flexion
changes from baseline to final session
Measured: 4th week
ROM ankle plantar flexion
changes from baseline to final session
Measured: 4th week
ROM ankle inversion
changes from baseline to final session
Measured: 4th week
ROM ankle eversion
changes from baseline to final session
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start10 Apr 2023
- Primary completion15 Jan 2024 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Behavior, SocialStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramsha Tariq, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086600
- Sponsor's protocol ID
- RCRAHS-ISB/REC/MS-PT/01610
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chien HL, Lu TW, Liu MW. Effects of long-term wearing of high-heeled shoes on the control of the body's center of mass motion in relation to the center of pressure during walking. Gait Posture. 2014 Apr;39(4):1045-50. doi: 10.1016/j.gaitpost.2014.01.007. Epub 2014 Jan 19.
PubMed 24508016Pannell SL. The postural and biomechanical effects of high heel shoes: a literature review. Journal of Vascular Surgery. 2012.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Instrument Assisted Soft Tissue Mobilization Versus Dynamic Oscillatory Stretch Technique in Females Wearing High Heels
- ClinicalTrials.gov ID
- NCT06086600
- Acronym / sponsor ID
- RCRAHS-ISB/REC/MS-PT/01610
- Conditions
- Behavior, Social
- Keywords
- instrument assisted soft tissue mobilization, dynamic oscillatory stretch technique, high heel users
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 17 Oct 2023 (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.
Rationale of this research is to compare the effect of instrument assisted soft tissue mobilization and dynamic oscillatory stretch technique on gastro soleus muscles flexibility with shortened calf muscle-tendon unit (MTU),thicker and stiffer Achilles tendon in individual wearing high heel. This study will observe effect in all range of motion of ankle joint. In Pakistan no previous research is conducted, that compare the effect of IASTM and DOST in females wearing high heel.
Detailed description
Regular wearing of high heels would lead to shortening of the fascicles of the gastrocnemius muscle together with changes in the mechanical properties of the Achilles' Tendon, by the continuous ankle plantar flexion cause by the heel lift resulting in functional alteration. The purpose of the study is to identify the optimal technique for alleviating the symptoms in patients with high heel syndrome. It is a randomized controlled trial.Sample size is total 54 participants which would be divided into two groups, 27 each.Non-probability Convenience Sampling will be used and participants are randomly assigned into GROUP A(IASTM) and GROUP B (DOST) through sealed envelope methods after baseline assessment. All participants in both groups were evaluated on two occasions: (i) baseline (ii) at 12th session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilization | Experimental | Other: Instrument Assisted Soft Tissue MobilizationGraston tool on gastrocnemius and soleus muscle. Conventional treatment will include * Hot pack for 10-15 min (calf muscles) * Stretching exercises of gastro-soleus (10reps x 2Sets). * Post session : Cold pack for 5 minutes (calf muscles) |
| Dynamic oscillatory stretch technique | Active comparator | Other: Dynamic oscillatory stretch techniqueDynamic oscillatory stretch technique on gastrocnemius and soleus muscle10reps x2 second hold oscillation x 3 sets. Conventional treatment will include * Hot pack for 10-15 min (calf muscles) * Stretching exercises of gastro-soleus (10reps x 2 Sets). * Post session : Cold pack for 5 minutes (calf Muscles |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 20-40 years
- Duration of wearing heels: minimum 1 year
- Wearing heels for minimum 3 times a week and 5 hours a day.
- Heel height: 2" and above
- Ankle Dorsiflexion ROM: decreased dorsiflexion (about 17 degrees)
Key exclusion criteria (4 listed)
- DVT
- Musculoskeletal injury or surgery of lower limb.
- Acute Cardio-Respiratory or Neurological condition.
- Medical or surgical co-morbidities
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 |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilizationgive gentle strokes from proximal to distal to check for trigger point or taut band. After knowing the exact location, give gentle strokes with minimal pressure in all directions by keeping the instrument in 30 to 60 degree angle. Application time will be between 40- 120 seconds. Conventional treatment will include * Hot pack for 10-15 min (calf muscles) * Stretching exercises of gastro-soleus (10reps x 2Sets). * Post session : Cold pack for 5 minutes (calf muscles) | Other | Instrument Assisted Soft Tissue Mobilization |
| Dynamic oscillatory stretch techniquePassively dorsiflexe the ankle to a point of the first stretch sensation. The next component to DOS, 2- second, passive stretch with slow oscillations at end range was applied. This procedure is repeated 10 times in each set with total of 3 sets .Therefore,10reps x2 second hold oscillation x 3 sets are given.Conventional treatment will include * Hot pack for 10-15 min (calf muscles) * Stretching exercises of gastro-soleus (10reps x 2Sets). * Post session : Cold pack for 5 minutes (calf muscles | Other | Dynamic oscillatory stretch technique |
Primary outcome
Ankle Range of Motion
Time frame: 4th week
Goniometer is used to measure ankle dorsiflexion, Plantarflexion, inversion, eversion ROM and it is use to assess and monitor patient's mobility to track progress during rehabilitation.
Lower Extremity Functional Scale (LEFS)
Time frame: 4th week
The Lower Extremity Functional Scale (LEFS) is a commonly used tool in physical therapy and rehabilitation to assess the functional abilities of patients with lower extremity impairments. It is a self-reported questionnaire that consists of 20 items, each with five response options ranging from 0 (unable to perform) to 4 (able to perform without difficulty). The scores on the LEFS range from 0 to 80, with higher scores indicating better function.
NUMERIC PAIN RATING SCALE
Time frame: 4th week
The numeric pain rating scale is used to measure pain intensity. It typically ranges from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain. Patients are asked to rate their pain on this scale, with the healthcare provider using the rating to help guide treatment decisions. It is a simple and effective way to communicate pain intensity, and can be useful in tracking changes in pain over time.
4 secondary outcomes
ROM ankle dorsi flexion
Time frame: 4th week
ROM ankle plantar flexion
Time frame: 4th week
ROM ankle inversion
Time frame: 4th week
ROM ankle eversion
Time frame: 4th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Background: PubMed 24508016Chien HL, Lu TW, Liu MW. Effects of long-term wearing of high-heeled shoes on the control of the body's center of mass motion in relation to the center of pressure during walking. Gait Posture. 2014 Apr;39(4):1045-50. doi: 10.1016/j.gaitpost.2014.01.007. Epub 2014 Jan 19.
- BackgroundPannell SL. The postural and biomechanical effects of high heel shoes: a literature review. Journal of Vascular Surgery. 2012.
- 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.
Ramsha Tariq, MS-OMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument Assisted Soft Tissue Mobilization and Dynamic oscillatory stretch technique in people with Behavior, Social, run by Riphah International University 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 6 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: status not confirmed, as of the sponsor's last update on 17 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramsha Tariq, MS-OMPT (03315251422, ramsha.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle Range of Motion (time frame: 4th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06086600, which also lists 2 linked publications.
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 17 Oct 2023.