Effects of Deep Transverse Friction Massage and Instrument Assisted Soft Tissue Mobilization in Plantar Fasciitis.

May 4, 2026 updated by: Riphah International University

Comparative Effects of Deep Transverse Friction Massage and Instrument Assisted Soft Tissue Mobilization Techniques on Pain Intensity, Disability and Functional Capacity in Plantar Fasciitis.

The objective of study is to compare the pain intensity, disability and functional capacity by Deep Transverse Friction Massage and Instrument Assisted Soft Tissue Mobilization Techniques in patients with plantar fasciitis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This randomized clinical trial will be conducted at Ghurki Trust and Teaching Hospital and Jinnah Hospital, Lahore. The study will target pregnant females aged 18 to 40 years who are clinically diagnosed with plantar fasciitis using the Windlass test. Exclusion criteria include a history of ankle or foot fracture or surgery within the past six months, as well as any neurological deficits. A total of 52 participants will be recruited using the non-probability convenience sampling technique and randomly assigned into two equal groups. Participants in both groups will receive the same baseline treatment. Group A will receive Deep Transverse Friction Massage (DTFM), while Group B will receive Instrument Assisted Soft Tissue Mobilization Techniques (IASTMT). The study aims to compare the effectiveness of these two manual therapy techniques on pain intensity, disability, and functional capacity. The Numeric Pain Rating Scale (NPRS) will be used to assess pain levels. Disability will be evaluated using the Foot Function Index (FFI), and the 6-Minute Walk Test (6MWT) will be employed to measure functional capacity. Data collected from participants will be entered and statistically analyzed using SPSS version 21 to determine the comparative effectiveness of the two treatment approaches in managing plantar fasciitis during pregnancy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 6400
        • Recruiting
        • Riphah medical center
        • Contact:
        • Principal Investigator:
          • Barera Fatima, MSPT(WH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant females Second trimester 12th to 34th week
  • Multiparous
  • Plantar fasciitis diagnoses with Windlass test
  • NPRS pain level 3 to 7

Exclusion Criteria:

  • History of ankle and foot fractures

  • Surgery in previous 6 months

    • Neurologic deficit High risk pregnancy
  • Previous manual therapy interventions for the foot region
  • Those who previously received systemic or local steroid injection within 3 months or locally injected with any other material
  • Dermatological disease i.e; injury, trauma, foot ulcer over the foot

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DEEP TRANSVERSE FRICTION MASSAGE
Deep friction massage (DFM), also known as cross friction massage, is a specific connective tissue massage
Other: DEEP TRANSVERSE FRICTION MASSAGE
12 sessions total (approx.1 and half month) and 2 sessions per week with mild to moderate manual pressure. 15 - 20 min per session will be given to patient for 6 weeks
Experimental: INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION TECHNIQUES
ASTM techniques involve the use of specialized instruments to manipulate soft tissue structures. These instruments are designed to provide an efficient detection of soft tissue dysfunction and accurate application of force during treatment.
Other: INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION TECHNIQUES
• 12 sessions total, (approximately 1 and half month) and 2 sessions per week. Low to moderate pressure with tool will applied for 15 - 20 min per session for 6 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NPRS)
Time Frame: 6th week
The Numeric Pain Rating Scale (NPRS) was employed to evaluate pain intensity for all participants in both groups prior to and following the 8-week intervention program. This is 11-point (0-10) self-reporting tool is presented as a 10-cm horizontal line where 0 indicates no pain, 1-3 signifies mild pain, 4-6 represents moderate pain, and 7-10 denotes severe pain. The maximum value corresponds to the worst pain, while the minimum value indicates the absence of pain.
6th week
Foot Function Index (FFI)
Time Frame: 6th week
A Foot Function Index (FFI) was developed to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales. Both total and sub-scale scores are produced.
6th week
6 min walk test (6MWT)
Time Frame: 6th week
used to determine functional ability. The individual walked swiftly for six minutes along a 100-foot hallway, recording the distance travelled in total. If a person with plantar fasciitis has pain or discomfort in the foot during the test, it can suggest the presence of the condition. During the 6-minute walk test, look for indicators of plantar fasciitis as follows.
6th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: sobia ghafoor, MSPT-OM, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Sahr ME, Grünebaum A, Positano RC, Nwawka OK, Chervenak FA, Positano RG. Common foot and ankle disorders in pregnancy: the role of diagnostic ultrasound. Journal of perinatal medicine. 2024;52(7):674-87
  • Foraldy J, Jehosua S, Momole A, Tumewah R, Runtuwene T, Wariki WMV. Plantar Fascia Thickness Difference Between Pregnant and Nulliparous in Indonesia. Journal of Medical Ultrasound. 2024;32(4):323-8.
  • Khairy E, Esmail A, Amin FS, Qudahh MA, Zahran MR. Integrated Neuromuscular Inhibition Technique versus Instrument Assisted Soft Tissue Mobilization in Patients with Chronic Plantar Fasciitis. Egyptian Journal of Hospital Medicine. 2024;96(1):2570-7.
  • Pisirici P, Cil ET, Coskunsu DK, Saylı U, Subasi F. Extracorporeal shockwave therapy versus graston instrument-assisted soft-tissue mobilization in chronic plantar heel pain: a randomized controlled trial. Journal of the American Podiatric Medical Association. 2022;112(6).
  • Gala M, Kulkarni P, Kumar A. Comparison of immediate effect of plantar fascia release by roller massager and transverse friction massage on hamstring flexibility in desk job workers. Int J Physiother Res. 2021;9:3954-9.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR & AHS/25/0501

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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