INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATIONNCT05256433
Role of Soft Tissue Therapy in Plantar Fasciitis
A study testing Group-A and Group-B in people with INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION, run by Ziauddin University at 1 site in Pakistan.
Trial summary
Plantar Fasciitis (PF) is a frequently and commonly reported heel pain present in every age with multifactorial etiology. It is the most common reason for constant heel pain in adults affecting both young active and older sedentary individuals. PF is reported approx. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION
- What is being tested?
- Group-A and Group-B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2021to 1 Aug 2022
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -Pre-diagnosed adults (18-55 years) with plantar fasciitis of both genders.
Who cannot join
- Pathological bone spurs of the calcaneus
- Burn scars
- Polyneuropathies
- Corticosteroid injections
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Javeria Mirza
Karachi, 75290
Ucksy Mallick, M.B.Bs,F.C.P.S-1, (021) 34822261, umallick@hotmail.com
About this study
Official title: Effectiveness of Instrument Assisted Soft Tissue Mobilization (IASTM) And Manual Massage On Thickness, Pain and Foot Function Among Patient With Plantar Fasciitis
Plantar Fasciitis (PF) is a frequently and commonly reported heel pain present in every age with multifactorial etiology. It is the most common reason for constant heel pain in adults affecting both young active and older sedentary individuals. PF is reported approx. 11%-15% of all foot symptoms demanding professional care among adults. Instrument-Assisted Soft Tissue Massage (IASTM) refers to a technique that utilizes instruments to eliminate scar tissues and work with mending measure through development of new extracellular lattice proteins like collagen that may be effective in providing immediate and quick pain relief by covering a larger area. On the other hand, numerous options with conservative measures has been frequently documented in treating plantar fasciitis that may include stretching, massage, orthosis, anti-inflammatory agents and surgery etc. Although, transverse friction massage has been considered to be one of the best treatment option in reducing pain, releasing tight areas and promoting flexibility. Besides, several studies reported the usefulness of potential assessment tools for remote monitoring of patients that can be utilized by clinicians for wider range of purposes. To the best of author's knowledge, limited studies has been conducted till date utilizing the IASTM technique in comparison to conservative treatment options with standardized assessments in treating PF. Therefore, this study aims to investigate the effectiveness of IASTM to assess thickness, pain, and foot function by using ultrasound for the management of plantar fasciitis patients. The findings of this study may be useful to establish an effective treatment protocol to enhance the quality of life of the target population.
- Being tested
- Group-A, Group-B
- Keywords
- Musculoskeletal Pain, Myofascial Release, Plantar Fasciitis
- Medical subject headings
- Musculoskeletal Pain, Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-AOther
IASTM Certified IASTM practitioner will be performing the technique with emollient lubricant in which brushing and sweeping stroke will be applied for plantar fascia and fanning and sweeping stroke technique for calf muscles for the duration of 10 minutes to eliminate the inflammation. Active calf stretching and passive plantar fascia stretching will be performed for the correction of shortened tissue, and to prevent re-injury. The frequency stretching will be 5 repetitions for each with 10 seconds hold.
Group-BOther
Manual massage includes transverse friction massage for plantar fascia, flexor digitorum brevis, and deep massage for calf muscle for the duration of 10 minutes to eliminate the tightness and increase the blood flow. Active calf stretching and passive plantar fascia stretching will be performed for the correction of shortened tissue, and to prevent re-injury.
| Study group | Role | What they receive |
|---|---|---|
| IASTM | Experimental | Not described Receives: Other: Group-A |
| Transverse friction massage | Active comparator | Not described Receives: Other: Group-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
It is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Measured: Baseline
NPRS
It is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Measured: 4 weeks
FAAM
This self-report outcome instrument is available in English, German, French and Persian. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.
Measured: Baseline
FAAM
This self-report outcome instrument is available in English, German, French and Persian. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.
Measured: 4 weeks
Diagnostic Ultrasound
Ultrasound imaging is a noninvasive technique, that uses sound waves to produce pictures of muscles, tendons, ligaments, nerves and joints throughout the body. Ultrasound is extensively used in the radiological department now it is being utilized in the diagnosis of Musculoskeletal related conditions and increasingly being used as an extension to physical examination. In plantar fasciitis, it is used for the measurement of plantar fascia.In symptomatic patients measured <4mm mm in comparison with asymptomatic patients 2.3-4 mm with hyperechoic in nature.
Measured: Baseline
Diagnostic Ultrasound
Ultrasound imaging is a noninvasive technique, that uses sound waves to produce pictures of muscles, tendons, ligaments, nerves and joints throughout the body. Ultrasound is extensively used in the radiological department now it is being utilized in the diagnosis of Musculoskeletal related conditions and increasingly being used as an extension to physical examination. In plantar fasciitis, it is used for the measurement of plantar fascia.In symptomatic patients measured <4mm mm in comparison with asymptomatic patients 2.3-4 mm with hyperechoic in nature.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Aug 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATIONStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafiza Javeria, Ziauddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256433
- Sponsor's protocol ID
- Ziauddin University
- Status last verified
- Feb 2022
- First submitted
- 4 Feb 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Instrument Assisted Soft Tissue Mobilization (IASTM) And Manual Massage On Thickness, Pain and Foot Function Among Patient With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT05256433
- Acronym / sponsor ID
- Ziauddin University
- Keywords
- Musculoskeletal Pain, Myofascial Release, Plantar Fasciitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 25 Feb 2022 (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.
Plantar Fasciitis (PF) is a frequently and commonly reported heel pain present in every age with multifactorial etiology. It is the most common reason for constant heel pain in adults affecting both young active and older sedentary individuals. PF is reported approx. 11%-15% of all foot symptoms demanding professional care among adults. Instrument-Assisted Soft Tissue Massage (IASTM) refers to a technique that utilizes instruments to eliminate scar tissues and work with mending measure through development of new extracellular lattice proteins like collagen that may be effective in providing immediate and quick pain relief by covering a larger area. On the other hand, numerous options with conservative measures has been frequently documented in treating plantar fasciitis that may include stretching, massage, orthosis, anti-inflammatory agents and surgery etc. Although, transverse friction massage has been considered to be one of the best treatment option in reducing pain, releasing tight areas and promoting flexibility. Besides, several studies reported the usefulness of potential assessment tools for remote monitoring of patients that can be utilized by clinicians for wider range of purposes. To the best of author's knowledge, limited studies has been conducted till date utilizing the IASTM technique in comparison to conservative treatment options with standardized assessments in treating PF. Therefore, this study aims to investigate the effectiveness of IASTM to assess thickness, pain, and foot function by using ultrasound for the management of plantar fasciitis patients. The findings of this study may be useful to establish an effective treatment protocol to enhance the quality of life of the target population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IASTM | Experimental | Other: Group-A |
| Transverse friction massage | Active comparator | Other: Group-B |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Pre-diagnosed adults (18-55 years) with plantar fasciitis of both genders.
Key exclusion criteria (4 listed)
- Pathological bone spurs of the calcaneus
- Burn scars
- Polyneuropathies
- Corticosteroid injections
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 |
|---|---|---|
| Group-AIASTM Certified IASTM practitioner will be performing the technique with emollient lubricant in which brushing and sweeping stroke will be applied for plantar fascia and fanning and sweeping stroke technique for calf muscles for the duration of 10 minutes to eliminate the inflammation. Active calf stretching and passive plantar fascia stretching will be performed for the correction of shortened tissue, and to prevent re-injury. The frequency stretching will be 5 repetitions for each with 10 seconds hold. | Other | IASTM |
| Group-BManual massage includes transverse friction massage for plantar fascia, flexor digitorum brevis, and deep massage for calf muscle for the duration of 10 minutes to eliminate the tightness and increase the blood flow. Active calf stretching and passive plantar fascia stretching will be performed for the correction of shortened tissue, and to prevent re-injury. | Other | Transverse friction massage |
Primary outcome
NPRS
Time frame: Baseline
It is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
NPRS
Time frame: 4 weeks
It is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
FAAM
Time frame: Baseline
This self-report outcome instrument is available in English, German, French and Persian. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.
FAAM
Time frame: 4 weeks
This self-report outcome instrument is available in English, German, French and Persian. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.
Diagnostic Ultrasound
Time frame: Baseline
Ultrasound imaging is a noninvasive technique, that uses sound waves to produce pictures of muscles, tendons, ligaments, nerves and joints throughout the body. Ultrasound is extensively used in the radiological department now it is being utilized in the diagnosis of Musculoskeletal related conditions and increasingly being used as an extension to physical examination. In plantar fasciitis, it is used for the measurement of plantar fascia.In symptomatic patients measured <4mm mm in comparison with asymptomatic patients 2.3-4 mm with hyperechoic in nature.
Diagnostic Ultrasound
Time frame: 4 weeks
Ultrasound imaging is a noninvasive technique, that uses sound waves to produce pictures of muscles, tendons, ligaments, nerves and joints throughout the body. Ultrasound is extensively used in the radiological department now it is being utilized in the diagnosis of Musculoskeletal related conditions and increasingly being used as an extension to physical examination. In plantar fasciitis, it is used for the measurement of plantar fascia.In symptomatic patients measured <4mm mm in comparison with asymptomatic patients 2.3-4 mm with hyperechoic in nature.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-A and Group-B in people with INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION, run by Ziauddin 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 1 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 25 Feb 2022. 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 javeria mirza, BSPT,D.DPT (03023314129, javeria.mirza@zu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPRS (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2022.