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

Behavior, Social Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06086600
• Other study ID #: RCRAHS-ISB/REC/MS-PT/01610
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: October 2023
• Source: Riphah International University
• Contact: Ramsha Tariq, MS-OMPT
• Phone: 03315251422
• Email: ramsha.tariq[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Social

Intervention

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)
• 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

Locations

Country	Name	City	State
Pakistan	Gulberg green campus of Riphah International University	Islamabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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. — View Citation

Pannell SL. The postural and biomechanical effects of high heel shoes: a literature review. Journal of Vascular Surgery. 2012.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	ROM ankle dorsi flexion	changes from baseline to final session	4th week
Secondary	ROM ankle plantar flexion	changes from baseline to final session	4th week
Secondary	ROM ankle inversion	changes from baseline to final session	4th week
Secondary	ROM ankle eversion	changes from baseline to final session	4th week