Plantar FascitisNCT05775302
Instrument-Assisted Soft Tissue Mobilization on Gastrocnemius and Achilles Tendon in Plantar Fasciitis
A study testing IASTM of Gastrocnemius + Conventional therapy and IASTM of AchillesTendon + Conventional Therapy in people with Plantar Fascitis, run by Riphah International University at 2 sites in Pakistan.
Trial summary
Aim of this study is to compare the effects of instrument assisted soft tissue mobilization on gastrocnemius and Achilles tendon on pain,range of motion and foot disability.A randomized control trial that will include total 32 participants and divided into two groups.Patients in Group A will receive instrument… Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- IASTM of Gastrocnemius + Conventional therapy and IASTM of AchillesTendon + Conventional Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Mar 2023to 15 Sep 2023
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both male and female
- Participants between age of 25 and 50 years
- Patients with maximal pain located at the antero-medial aspect of the plantar surface of the calcaneus
- Pain aggravated by passive dorsiflexion or standing/ walking on the big toe
- Patients with pain on taking first step in the morning(18)
- Patient volunteer to participate in the study and signed informed consent.
Who cannot join
- Patient with history of musculoskeletal disorders.
- Patient with any previous history of ankle or foot surgery.
- Patient with history of ankle or foot fracture.
- Patient with severe bone disorder (osteoporosis)
- Patient with history of Venous insufficiency.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Adam Life Care
Rawalpindi, Punjab Province, 43600
Attock Hospital
Rawalpindi, Punjab Province, 43600
About this study
Official title: Effects of Instrument-Assisted Soft Tissue Mobilization on Gastrocnemius and Achilles Tendon in Plantar Fasciitis
Aim of this study is to compare the effects of instrument assisted soft tissue mobilization on gastrocnemius and Achilles tendon on pain,range of motion and foot disability.A randomized control trial that will include total 32 participants and divided into two groups.Patients in Group A will receive instrument assisted soft tissue mobilization of gastrocnemius and Group B will receive instrument assisted soft tissue mobilization of Achilles tendon. While conventional therapy will be given to both groups.Data collected will be analyzed through SPSS 25.
Read the detailed description
Plantar fasciitis is typical condition that produces pain in the medial longitudinal arch of the foot.Repetitive traction stresses on the plantar fascia at its origin over the distal calcaneus obesity, the makeup of the feet, and lifestyle choices are all factors that might contribute to the development of PF.
Physiotherapy interventions includes stretching the gastrocnemius and soleus,dry needling, IASTM (instrument assisted soft tissue mobilisation), exercise therapy, ultrasound therapy, iontophoresis, laser therapy, splints, and taping.Use of Instrument-Assisted Soft Tissue Massage has increased in popularity, and the plantar fascia is a superficial tissue that may benefit from this treatment.The Graston Technique Instrument-assisted Soft Tissue Mobilisation not only increases blood flow and tissue healing to the area as well as breaking up soft tissue restrictions along with increase fibroblasts, mast cell production and phagocytes.
Previous literature were limited in sample size, and only immediate effects of these techniques were studied But this study opted for the long term use of graston technique on gastrocnemius in comparison on Achilles tendon. So the purpose of this study is to compare the effects of Graston technique instrument assisted soft tissue mobilization at gastrocnemius and Achilles tendon in patients with planter fascitis. It will add to the growing body of knowledge that if same technique on different soft tissues will yield comparable outcomes,which should be the alternate choice of therapy
- Conditions
- Plantar Fascitis
- Being tested
- IASTM of Gastrocnemius + Conventional therapy, IASTM of AchillesTendon + Conventional Therapy
- Keywords
- plantar Fascitis, Ache, Joint Range of Motion, Disability
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IASTM of Gastrocnemius + Conventional therapyOther
The SWEEP technique will be performed downwards from the popliteal region to the Achilles tendon for 60 seconds, 30 times 12 sessions over a time frame of 4 weeks at a frequency of 3 sessions per week.
IASTM of AchillesTendon + Conventional TherapyOther
Participants will receive a maximum of 60 seconds<30 times 12 sessions over a time frame of 4 weeks at a frequency of 3 sessions per week.
| Study group | Role | What they receive |
|---|---|---|
| IASTM Gastrocnemius | Experimental | Instrument assisted soft tissue mobilization on gastrocnemius
Conventional therapy:
Cryotherapy for 10 min stretching of calf and plantar fascia strengthning of intrinsic foot muscle Receives: Other: IASTM of Gastrocnemius + Conventional therapy |
| IASTM Achillies Tendon | Active comparator | Instrument assisted soft tissue mobilization Achillies Tendon
Conventional therapy:
Cryotherapy for 10 min stretching of calf and plantar fascia strengthning of intrinsic foot muscle Receives: Other: IASTM of AchillesTendon + Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Visual analogue scale id used to measures pain intensity. It consists of a 10cm line, with two end points representing 0 ('no pain') and 10 (pain as bad as it could possibly be)
Measured: 4 weeks
Secondary outcomes (2)
Goniometer
Goniometer is used to measure the ROM of joints
Measured: 4 weeks
Foot and ankle disability index
Foot and Ankle Disability Index is a 34-item questionnaire divided into two subscales.
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 posted20 Mar 2023
- Study start15 Mar 2023
- Primary completion15 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madiha Ali, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775302
- Sponsor's protocol ID
- Parwasha Shoukat
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2023
- Last updated
- 13 Mar 2024
- 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 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Instrument-Assisted Soft Tissue Mobilization on Gastrocnemius and Achilles Tendon in Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT05775302
- Acronym / sponsor ID
- Parwasha Shoukat
- Conditions
- Plantar Fascitis
- Keywords
- plantar Fascitis, Ache, Joint Range of Motion, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 20 Mar 2023 (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.
Aim of this study is to compare the effects of instrument assisted soft tissue mobilization on gastrocnemius and Achilles tendon on pain,range of motion and foot disability.A randomized control trial that will include total 32 participants and divided into two groups.Patients in Group A will receive instrument assisted soft tissue mobilization of gastrocnemius and Group B will receive instrument assisted soft tissue mobilization of Achilles tendon. While conventional therapy will be given to both groups.Data collected will be analyzed through SPSS 25.
Detailed description
Plantar fasciitis is typical condition that produces pain in the medial longitudinal arch of the foot.Repetitive traction stresses on the plantar fascia at its origin over the distal calcaneus obesity, the makeup of the feet, and lifestyle choices are all factors that might contribute to the development of PF.
Physiotherapy interventions includes stretching the gastrocnemius and soleus,dry needling, IASTM (instrument assisted soft tissue mobilisation), exercise therapy, ultrasound therapy, iontophoresis, laser therapy, splints, and taping.Use of Instrument-Assisted Soft Tissue Massage has increased in popularity, and the plantar fascia is a superficial tissue that may benefit from this treatment.The Graston Technique Instrument-assisted Soft Tissue Mobilisation not only increases blood flow and tissue healing to the area as well as breaking up soft tissue restrictions along with increase fibroblasts, mast cell production and phagocytes.
Previous literature were limited in sample size, and only immediate effects of these techniques were studied But this study opted for the long term use of graston technique on gastrocnemius in comparison on Achilles tendon. So the purpose of this study is to compare the effects of Graston technique instrument assisted soft tissue mobilization at gastrocnemius and Achilles tendon in patients with planter fascitis. It will add to the growing body of knowledge that if same technique on different soft tissues will yield comparable outcomes,which should be the alternate choice of therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IASTM Gastrocnemius | Experimental | Other: IASTM of Gastrocnemius + Conventional therapyInstrument assisted soft tissue mobilization on gastrocnemius Conventional therapy: Cryotherapy for 10 min stretching of calf and plantar fascia strengthning of intrinsic foot muscle |
| IASTM Achillies Tendon | Active comparator | Other: IASTM of AchillesTendon + Conventional TherapyInstrument assisted soft tissue mobilization Achillies Tendon Conventional therapy: Cryotherapy for 10 min stretching of calf and plantar fascia strengthning of intrinsic foot muscle |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both male and female
- Participants between age of 25 and 50 years
- Patients with maximal pain located at the antero-medial aspect of the plantar surface of the calcaneus
- Pain aggravated by passive dorsiflexion or standing/ walking on the big toe
- Patients with pain on taking first step in the morning(18)
Key exclusion criteria (5 listed)
- Patient with history of musculoskeletal disorders.
- Patient with any previous history of ankle or foot surgery.
- Patient with history of ankle or foot fracture.
- Patient with severe bone disorder (osteoporosis)
- Patient with history of Venous insufficiency.
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 |
|---|---|---|
| IASTM of Gastrocnemius + Conventional therapyThe SWEEP technique will be performed downwards from the popliteal region to the Achilles tendon for 60 seconds, 30 times 12 sessions over a time frame of 4 weeks at a frequency of 3 sessions per week. | Other | IASTM Gastrocnemius |
| IASTM of AchillesTendon + Conventional TherapyParticipants will receive a maximum of 60 seconds<30 times 12 sessions over a time frame of 4 weeks at a frequency of 3 sessions per week. | Other | IASTM Achillies Tendon |
Primary outcome
Visual Analogue Scale
Time frame: 4 weeks
Visual analogue scale id used to measures pain intensity. It consists of a 10cm line, with two end points representing 0 ('no pain') and 10 (pain as bad as it could possibly be)
2 secondary outcomes
Goniometer
Time frame: 4 weeks
Foot and ankle disability index
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Plantar Fascitis
Not yet recruiting
Efficacy of TECAR Therapy in Plantar Fasciitis
Plantar Fasciitis
Active, not recruiting
Active Release Technique vs. Dynamic Soft Tissue Mobilization for Plantar Pain
Plantar Fascitis
Not yet recruiting
Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
Recruiting
F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
Plantar Fascitis, Chronic Heel Pain
Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
Plantar Fasciitis, Chronic
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.
Madiha Ali, MSOMPT principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IASTM of Gastrocnemius + Conventional therapy and IASTM of AchillesTendon + Conventional Therapy in people with Plantar Fascitis, run by Riphah International University at 2 sites 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 4 weeks). 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 13 Mar 2024.