Chronic Plantar FasciitisNCT05162144
Proximal Medial Gastriocnemius Recession for Chronic Plantar Fasciitis
A study testing Proximal Medial Gastrocnemius Recession in people with Chronic Plantar Fasciitis, run by Ostfold Hospital Trust at 1 site in Norway.
Trial summary
This prospective kohort study will follow 150 patients treated with proximal medial gastrocnemius recession for plantar fasciitts. Follow up time is two years and the main outcome is the Manchester Oxford Foot Questionnaire. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Plantar Fasciitis
- What is being tested?
- Proximal Medial Gastrocnemius Recession
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- 15 Dec 2021to 15 Mar 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years.
- Diagnosis plantar fasciitis verified clinically by orthopaedic surgeon.
- Diagnosis verified by MRI. MRI criteria: Thickening of the plantar fascia, oedema in the calcaneus, pathological singal changes in the plantar fascia (37)
- Duration of symptoms must be at least 12 months.
- An isolated gastrocnemius contracture must be verified with the Silverskiölds test before inclusion.
- Conventional Physical Therapy must have been tried at least three months without positive effects on symptoms from affected foot.
Who cannot join
- Previously undergone surgery for plantar fasciitis.
- Patients with severe talocrural pathology or serious malalignment of foot and ankle
- Severely reduced peripheral circulation or chronic ulcerations of the foot
- History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent.
- Patients with a contraindication/non-compliance for MRI examination.
- Unable to walk without aid.
- Not able to read and/or speak a Scandinavian language or English adequately.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proximal Medial Gastriocnemius Recession for Chronic Plantar Fasciitis - a Prospective Kohort Study
This prospective kohort study will follow 150 patients treated with proximal medial gastrocnemius recession for plantar fasciitts. Follow up time is two years and the main outcome is the Manchester Oxford Foot Questionnaire.
A regression analasys will be performed to identify possible patient baseline factors that may affect the effect of surgery,
Read the detailed description
Recent studies indicate that chronic plantar fasciitis can be treated effectively with Proximal Medial Gastrocnemius Recession (PMGR). In our hospital this treatment has been inocorporated into routine care. This prospective kohort study will follow 150 patients with chronic planatar fasciitis operated with PMGR study. The follow up time is 2 years and the study aims at documenting the effect of the surgery with PROMS (patient related outcome measures), MRI (magnetic resonnance imaging) and ankle movement measurements. 26 patient-related baseline factors will also be registered. A regression analysis will be performed to identify factors that may be predictive to the effect of PMGR surgery.
- Conditions
- Chronic Plantar Fasciitis
- Being tested
- Proximal Medial Gastrocnemius Recession
- Keywords
- proximal medial gastrocnemius recession, MOxFQ, VAS, EQ5D, MRI, Regression analysis, Ankle movement, Adverse events
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal Medial Gastrocnemius RecessionProcedure or surgery
Also called PMGR
Patients will be operated with PMGR as described by Barouk. No additional procedures will be performed. The surgery will be performed with the patients in a prone position under local anaesthetics. A 3-4 cm transverse skin incision is made in the popliteal fossa, the superficial fascia is opened, and the medial gastrocnemius with its tendon (aponeurosis) is located. The tendon is then cut while lifting it with clamps, and care is taken to cut only the white tendon while sparing the underlying muscle. While performing a dorsiflexion movement of the ankle, careful palpation of the muscle is done to ensure that all tendon strands are cut completely. The incision is closed in layers, and only soft dressings applied. Patients will be instructed to continue the stretching exercises and fully weight-bear from the first postoperative day. If needed, the patients will be allowed to use crutches during the first 2 weeks after surgery. Sutures are removed 2-3 weeks after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Proximal Medial Gastrocnemius Recession Surgery | Experimental | All patients included in the Cohort Study will recieve this PMGR-surgery Receives: Procedure: Proximal Medial Gastrocnemius Recession |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manchester Oxford Foot Questionnaire (MOxFQ)
Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
Measured: Baseline
Manchester Oxford Foot Questionnaire (MOxFQ)
Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
Measured: 6 weeks postoperatively
Manchester Oxford Foot Questionnaire (MOxFQ)
Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
Measured: 12 weeks postoperatively
Manchester Oxford Foot Questionnaire (MOxFQ)
Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
Measured: 1 year postoperatively
Manchester Oxford Foot Questionnaire (MOxFQ)
Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
Measured: 2 years postoperatively
Secondary outcomes (17)
VAS (visual analogue scale)
Visual analogue scale for pain during use of affected leg in the last 24 hours. 0 is no pain. 10 is worst pain imaginable.
Measured: Baseline, 12 weeks, 1 year, 2 years
EQ5D (EuroQol questionnaire )
EQ-5D is a validated generic health-related quality-of-life instrument. It consists of two parts: EQ-5D descriptive part and EQ-5D visual analogue scale. The descriptive part includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with three possible answers ("no problems", "some problems", and "major problems"). EQ5D VAS is a visual analogue scale of self-related overall health, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state
Measured: Baseline, 12 weeks, 1 year, 2 years
MRI (magnetic resonancd imaging) findings
Thickness of plantar fascia at insertion, pathological signals in the fascia yes/no more, less or same as before, presence of oedema in the calcaneal bone yes/no.
Measured: Baseline, 2years
Adverse events
infection, nerve injury, thrombosis.
Measured: Baseline, 6 weeks, 12 weeks, 1 year, 2 years
Ankle movement
Ankle dorsiflexion measured in degrees, through a validated gonimeter
Measured: Baseline, 12 weeks, 2 years
Gait analysis - Maximal ankle dorsiflexion during stance (degrees)
A sub-group of patients (n= 30) will be offered to be tested in a walking lab, comparing their ankle dorsiflexion during stance pre-and postoperatively. Due to a limited access to this facility, not all patients will be able to perform this test.
- Maximal ankle dorsiflexion during stance (degrees)
Measured: Baseline, 3 months
Gait analysis (Length of stride. Centimeters)
A sub-group of patients (n= 30) will be offered to be tested in a walking lab, comparing their ankle dorsiflexion during stance pre-and postoperatively. Due to a limited access to this facility, not all patients will be able to perform this test.
Measured: Baseline, 3 months
Gait analysis Ankle power
A sub-group of patients (n= 30) will be offered to be tested in a walking lab, comparing their ankle dorsiflexion during stance pre-and postoperatively. Due to a limited access to this facility, not all patients will be able to perform this test.
Measured: Baseline, 3 months
Gait analysis Cadence (steps/minute)
A sub-group of patients (n= 30) will be offered to be tested in a walking lab, comparing their ankle dorsiflexion during stance pre-and postoperatively. Due to a limited access to this facility, not all patients will be able to perform this test.
Measured: Baseline, 3 months
Gait analysis Maximal external rotation of ankle during stance (degrees)
A sub-group of patients (n= 30) will be offered to be tested in a walking lab, comparing their ankle dorsiflexion during stance pre-and postoperatively. Due to a limited access to this facility, not all patients will be able to perform this test.
- Maximal ankle dorsiflexion during stance (degrees)
- Length of stride. Centimeters
- Cadence (steps/minute)
- Ankle power
- Maximal external rotation of ankle during stance (degrees)
- Knee extension while maximal dorsiflexion of ankle during stance (degrees)
Measured: Baseline, 3 months
Gait analysis Knee extension while maximal dorsiflexion of ankle during stance (degrees)
A sub-group of patients (n= 30) will be offered to be tested in a walking lab, comparing their ankle dorsiflexion during stance pre-and postoperatively. Due to a limited access to this facility, not all patients will be able to perform this test.
Measured: Baseline, 3 months
Assessment of treatment success -pain
Likert question: I have pain in the heel pain in the leg that was operated two years ago Answers. 1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree
Measured: at 2 years
Assessment of treatment success - physical activity
Likert question:Heel pain prevents me from performing physical acitvity Answers. 1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree
Measured: at 2 years
Assessment of treatment success - daily living
Likert question:Heel pain prevents me from performing activities of daily living Answers. 1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree
Measured: at 2 years
Assessment of treatment success - other treatments
Likert question:I have pain and/or discomfort in the calf that was operated two years ago Answers. 1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree
Measured: at 2 years
Assessment of treatment success - patient acceptable symptom state
I have received other treatments for plantar fasciitis since surgery was performed two years ago YES/NO
Measured: at 2 years
Assessment of treatment success
If you were to continue having the same level of symptoms in the next few months, would you consider that acceptable.
YES/NO
Measured: at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start15 Dec 2021
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Plantar FasciitisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Cohort Study
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162144
- Sponsor's protocol ID
- REK317597
- Status last verified
- Apr 2024
- First submitted
- 1 Dec 2021
- Last updated
- 9 Apr 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Medial Gastriocnemius Recession for Chronic Plantar Fasciitis - a Prospective Kohort Study
- ClinicalTrials.gov ID
- NCT05162144
- Acronym / sponsor ID
- REK317597
- Conditions
- Chronic Plantar Fasciitis
- Keywords
- proximal medial gastrocnemius recession, MOxFQ, VAS, EQ5D, MRI, Regression analysis, Ankle movement, Adverse events
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 17 Dec 2021 (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.
This prospective kohort study will follow 150 patients treated with proximal medial gastrocnemius recession for plantar fasciitts. Follow up time is two years and the main outcome is the Manchester Oxford Foot Questionnaire.
A regression analasys will be performed to identify possible patient baseline factors that may affect the effect of surgery,
Detailed description
Recent studies indicate that chronic plantar fasciitis can be treated effectively with Proximal Medial Gastrocnemius Recession (PMGR). In our hospital this treatment has been inocorporated into routine care. This prospective kohort study will follow 150 patients with chronic planatar fasciitis operated with PMGR study. The follow up time is 2 years and the study aims at documenting the effect of the surgery with PROMS (patient related outcome measures), MRI (magnetic resonnance imaging) and ankle movement measurements. 26 patient-related baseline factors will also be registered. A regression analysis will be performed to identify factors that may be predictive to the effect of PMGR surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Cohort Study
| Arm | Type | Receives |
|---|---|---|
| Proximal Medial Gastrocnemius Recession Surgery | Experimental | Procedure: Proximal Medial Gastrocnemius RecessionAll patients included in the Cohort Study will recieve this PMGR-surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years.
- Diagnosis plantar fasciitis verified clinically by orthopaedic surgeon.
- Diagnosis verified by MRI. MRI criteria: Thickening of the plantar fascia, oedema in the calcaneus, pathological singal changes in the plantar fascia (37)
- Duration of symptoms must be at least 12 months.
- An isolated gastrocnemius contracture must be verified with the Silverskiölds test before inclusion.
Key exclusion criteria (7 listed)
- Previously undergone surgery for plantar fasciitis.
- Patients with severe talocrural pathology or serious malalignment of foot and ankle
- Severely reduced peripheral circulation or chronic ulcerations of the foot
- History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent.
- Patients with a contraindication/non-compliance for MRI examination.
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 |
|---|---|---|
| Proximal Medial Gastrocnemius RecessionAlso: PMGRPatients will be operated with PMGR as described by Barouk. No additional procedures will be performed. The surgery will be performed with the patients in a prone position under local anaesthetics. A 3-4 cm transverse skin incision is made in the popliteal fossa, the superficial fascia is opened, and the medial gastrocnemius with its tendon (aponeurosis) is located. The tendon is then cut while lifting it with clamps, and care is taken to cut only the white tendon while sparing the underlying muscle. While performing a dorsiflexion movement of the ankle, careful palpation of the muscle is done to ensure that all tendon strands are cut completely. The incision is closed in layers, and only soft dressings applied. Patients will be instructed to continue the stretching exercises and fully weight-bear from the first postoperative day. If needed, the patients will be allowed to use crutches during the first 2 weeks after surgery. Sutures are removed 2-3 weeks after surgery. | Procedure or surgery | Proximal Medial Gastrocnemius Recession Surgery |
Primary outcome
Manchester Oxford Foot Questionnaire (MOxFQ)
Time frame: Baseline
Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
Manchester Oxford Foot Questionnaire (MOxFQ)
Time frame: 6 weeks postoperatively
Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
Manchester Oxford Foot Questionnaire (MOxFQ)
Time frame: 12 weeks postoperatively
Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
Manchester Oxford Foot Questionnaire (MOxFQ)
Time frame: 1 year postoperatively
Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
Manchester Oxford Foot Questionnaire (MOxFQ)
Time frame: 2 years postoperatively
Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
17 secondary outcomes
VAS (visual analogue scale)
Time frame: Baseline, 12 weeks, 1 year, 2 years
EQ5D (EuroQol questionnaire )
Time frame: Baseline, 12 weeks, 1 year, 2 years
MRI (magnetic resonancd imaging) findings
Time frame: Baseline, 2years
Adverse events
Time frame: Baseline, 6 weeks, 12 weeks, 1 year, 2 years
Ankle movement
Time frame: Baseline, 12 weeks, 2 years
Gait analysis - Maximal ankle dorsiflexion during stance (degrees)
Time frame: Baseline, 3 months
Gait analysis (Length of stride. Centimeters)
Time frame: Baseline, 3 months
Gait analysis Ankle power
Time frame: Baseline, 3 months
Gait analysis Cadence (steps/minute)
Time frame: Baseline, 3 months
Gait analysis Maximal external rotation of ankle during stance (degrees)
Time frame: Baseline, 3 months
Gait analysis Knee extension while maximal dorsiflexion of ankle during stance (degrees)
Time frame: Baseline, 3 months
Assessment of treatment success -pain
Time frame: at 2 years
Assessment of treatment success - physical activity
Time frame: at 2 years
Assessment of treatment success - daily living
Time frame: at 2 years
Assessment of treatment success - other treatments
Time frame: at 2 years
Assessment of treatment success - patient acceptable symptom state
Time frame: at 2 years
Assessment of treatment success
Time frame: at 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Chronic Plantar Fasciitis
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
RecruitingObservational study
Tibial Nerve Size and Clinical Features in Chronic Plantar Fasciitis
Plantar Fasciitis, Chronic, Tibial Nerve
Recruiting
Acupuncture of Different Treatment Frequency in Chronic 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal Medial Gastrocnemius Recession in people with Chronic Plantar Fasciitis, run by Ostfold Hospital Trust at 1 site in Norway.
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 7 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 9 Apr 2024. 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 Norway. 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?
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?
Manchester Oxford Foot Questionnaire (MOxFQ) (time frame: Baseline). The study lists 5 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 9 Apr 2024.