Clinical trial NCT06086600: Instrument Assisted Soft Tissue Mobilization Versus Dynamic Oscillatory Stretch Technique in Females Wearing High Heels
Official title: Comparison of Instrument Assisted Soft Tissue Mobilization Versus Dynamic Oscillatory Stretch Technique in Females Wearing High Heels
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Behavior, Social
Keywords: instrument assisted soft tissue mobilization
dynamic oscillatory stretch technique
high heel users
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 54
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* DVT
* Musculoskeletal injury or surgery of lower limb.
* Acute Cardio-Respiratory or Neurological condition.
* Medical or surgical co-morbidities

Primary outcomes:
measure: Ankle Range of Motion
timeFrame: 4th week
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: 4th week
measure: NUMERIC PAIN RATING SCALE
timeFrame: 4th week
Secondary outcomes:
measure: ROM ankle dorsi flexion
timeFrame: 4th week
measure: ROM ankle plantar flexion
timeFrame: 4th week
measure: ROM ankle inversion
timeFrame: 4th week
measure: ROM ankle eversion
timeFrame: 4th week
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Gulberg green campus of Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Ramsha Tariq, MS-OMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Pannell SL. The postural and biomechanical effects of high heel shoes: a literature review. Journal of Vascular Surgery. 2012.