Instrument Assisted Soft Tissue Mobilization Versus Dynamic Oscillatory Stretch Technique in Females Wearing High Heels

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.

Study Overview

• Status: Recruiting
• Conditions: Behavior, Social
• Intervention / Treatment: Other: Instrument Assisted Soft Tissue Mobilization; Other: Dynamic oscillatory stretch technique

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 Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ramsha Tariq, MS-OMPT; Phone Number: 03315251422; Email: ramsha.tariq@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Islamabad, Punjab, Pakistan, 44000
      • Recruiting
      • Gulberg green campus of Riphah International University
      • Contact: Ramsha Tariq, MSOMPT; Phone Number: 03315251422; Email: ramsha.tariq@riphah.edu.pk
      • Principal Investigator: mehr un nisa, MS-OMPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Instrument Assisted Soft Tissue Mobilization; 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)	Other: Instrument Assisted Soft Tissue Mobilization; 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)
Active Comparator: Dynamic oscillatory stretch technique; 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	Other: Dynamic oscillatory stretch technique; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	4th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ROM ankle dorsi flexion	changes from baseline to final session	4th week
ROM ankle plantar flexion	changes from baseline to final session	4th week
ROM ankle inversion	changes from baseline to final session	4th week
ROM ankle eversion	changes from baseline to final session	4th week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Ramsha Tariq, MS-OMPT, Riphah International University

Publications and helpful links

General Publications

• Chien H-L, Lu T-W, Liu M-W. 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;39(4):1045-50.
• Pannell SL. The postural and biomechanical effects of high heel shoes: a literature review. Journal of Vascular Surgery. 2012.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Estimated): January 15, 2024
• Study Completion (Estimated): January 15, 2024

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: instrument assisted soft tissue mobilization; dynamic oscillatory stretch technique; high heel users
• Other Study ID Numbers: RCRAHS-ISB/REC/MS-PT/01610

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No