Plantar Fascitis Clinical Trial
Official title:
Immediate and 12-week Effects of Exercise Versus Exercise and Instrument-Assisted Soft Tissue Mobilization for Plantar Fasciopathy Treatment: A Randomized Controlled Trial
Verified date | February 2021 |
Source | Texas Tech University Health Sciences Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study compares the addition instrument-assisted soft tissue mobilization (IASTM) to a program of home strengthening and stretching exercises to see whether adding weekly IASTM treatments improves plantar fasciopathy pain and plantar fascia stiffness.
Status | Completed |
Enrollment | 83 |
Est. completion date | January 15, 2021 |
Est. primary completion date | January 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria for Plantar Fasciopathy Groups - age 18-60 years - self-reported history of plantar heel pain for a minimum of 2 months prior to enrollment - pain on palpation of the medial calcaneal tubercle or the proximal plantar fascia - pain is worst when first standing or walking after rest - willing to attempt not to use additional treatments (e.g., shoe modifications, foot orthoses/braces, injections, or surgery) during the trial period (12 weeks) - willing to attempt to discontinue taking all pain-relieving medications except Tylenol or ibuprofen for plantar heel pain during the trial period (12 weeks). Inclusion Criteria for Healthy Comparison Group: - age and BMI matched with Group 2 subjects - no history or symptoms of plantar heel pain in the past 12 months Exclusion Criteria for all three groups: - history of direct trauma to the foot with plantar fasciopathy - inflammatory arthritis in the feet/ankle (e.g., ankylosing spondylitis or rheumatoid arthritis) - metabolic or endocrine disorders (e.g., Type I or II diabetes) - neurological disorders (e.g., Charcot-Marie-Tooth disease) - prior foot surgery on the foot with plantar fasciopathy - pregnancy (by self-report) - corticosteroid injection to treat plantar fasciopathy in the past 12 weeks - body mass index > 35 kg/m2 - receiving or applied for worker compensation benefits - no physical activity above 5 (moderate activity) on a 10-point Rating of Perceived Exertion scale in the past 24 hours prior to the initial screening visit. |
Country | Name | City | State |
---|---|---|---|
United States | Texas Tech University Health Sciences Center | Lubbock | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University Health Sciences Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Foot Health Status Questionnaire Pain Subscale Score | This self-report questionnaire assesses individuals' foot health and function. The pain subscale evaluates type of pain and its severity and duration. | Week 8 | |
Secondary | Ankle range of motion | Ankle dorsiflexion range of motion will be measured while the subject performs a weight-bearing lunge while facing a wall. Subjects will keep their heels on the ground and may keep contact on the wall in front of them with two fingers to maintain balance. The knee will be aligned with the second toe with the first toe 10 cm away from the wall. To perform the test, subjects will bring their knee forward towards the wall, keeping it aligned with the second metatarsal. If the knee contacts the wall while maintaining the heel on the ground, the foot will be moved back 1 cm at a time until the heel raises off the ground during the test performance. The final distance between the wall and the first toe will be recorded, and the test will be repeated three times. | Baseline and weeks 4, 8, and 12 | |
Secondary | First metatarsophalangeal range of motions | First metatarsophalangeal (MTJ) joint range of motion will be measured using a 2D electrogoniometer (Noraxon Ultium, Scottsdale, AZ). The electrogoniometer will be placed along the ventral surface of the first metatarsal phalangeal joint. Subjects will stand with the feet shoulder-width apart. An investigator will lift the first toe and record dorsiflexion range of motion. No mid-foot or heel motion will be allowed during measurement. The range of motion will be measured three times. | Baseline and weeks 4, 8, and 12 | |
Secondary | Patient Acceptable Symptom State | Self-reported time to achieve a satisfactory result. | Baseline and weeks 4, 8, and 12. Phone visits at weeks 9, 10, 11. | |
Secondary | Credibility/Expectancy Questionnaire | Participants self-rate the credibility of the intervention and their expectations for recovery after they are informed of their group allocation but prior to any intervention. | Baseline visit | |
Secondary | Visual Analog Scale Pain Score | Heel pain severity on a 10-cm scale when getting out of bed in the morning | Baseline and weeks 4, 8, and 12. | |
Secondary | Plantar Fascia Shear Wave Velocity | Ultrasound Shear Wave Elastography (Aixplorer, Axe-En-Provence, France, Version 10) will be used to measure plantar fascia shear wave velocity (m/s) at the 0.5 cm distal to the proximal calcaneal insertion and at the level of the navicular in the midfoot. | week 0, 4, 8 and 12 | |
Secondary | The Foot Health Status Questionnaire Footwear Subscale Score | Evaluates lifestyle issues related to footwear and the feet. | Baseline and weeks 4, 8, and 12 | |
Secondary | The Foot Health Status Questionnaire General Foot Health Subscale Score | Evaluates participants' self-perception of their feet. | Baseline and weeks 4, 8, and 12 | |
Secondary | The Foot Health Status Questionnaire Foot Function Subscale Score | Evaluates the feet in terms of impact on physical function | Baseline and weeks 4, 8, and 12 | |
Secondary | Physical Activity Level | Measured using the International Physical Activity Questionnaire short form (IPAQ), which estimates weekly physical activity. | Baseline and weeks 4, 8, and 12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05071365 -
Early Access to Virtual Resources for the Self-management of Plantar Fasciitis
|
N/A | |
Not yet recruiting |
NCT05479526 -
Effect of The Superficial Back Line on the Development of Plantar Fasciitis
|
||
Not yet recruiting |
NCT05479500 -
Investigation of the Efficacy of Myofascial Chain Release Techniques on Plantar Fasciitis
|
N/A | |
Recruiting |
NCT04423900 -
Smart Phone-Based Application for Evaluation and Rehabilitation of HindFoot Pain
|
N/A | |
Completed |
NCT04204824 -
Ultrasound Treatment in the Management of Plantar Fasciitis
|
N/A | |
Completed |
NCT03246087 -
Acupuncture for Plantar Fasciosis in the Primary Care Setting
|
N/A | |
Completed |
NCT05647291 -
Is ESWT Better in Plantar Fasciitis Treatment?
|
N/A | |
Withdrawn |
NCT03873207 -
Offloading Device for Post Surgical Foot Procedures
|
N/A | |
Completed |
NCT05347264 -
Comparative Effects of Gun Massager and Transverse Friction Massage in Patients With Plantar Fasciitis
|
N/A | |
Recruiting |
NCT04175288 -
The Effectiveness of Ultrasound Treatment in the Management of Plantar Fasciitis
|
N/A | |
Completed |
NCT03731897 -
Evaluation of the Efficacy of Prolotherapy Treatment in Patients With Plantar Fasciitis: a Randomized Double-blind Study
|
N/A | |
Recruiting |
NCT05462002 -
Intrinsic Foot Muscle Morphology and Function in Runners With and Without Plantar Fasciitis
|
||
Active, not recruiting |
NCT06466616 -
Shock Waves Combined With Leg Stretches in Patients With Plantar Fasciitis
|
N/A | |
Completed |
NCT05207592 -
Urdu Version of Foot and Ankle Disability Index: A Reliability and Validity Study
|
||
Not yet recruiting |
NCT06394336 -
Early Intervention With Therapeutic Exercise in Plantar Fasciopathy
|
N/A | |
Completed |
NCT05867888 -
Shock Wave Therapy Versus Low Level Laser Therapy in Patients With Plantar Fasciitis
|
N/A | |
Completed |
NCT06023836 -
Myofascial Pain Syndrome and Plantar Fasciitis Treatment
|
N/A | |
Completed |
NCT05856019 -
Effects of J Stroke Myofascial Release in Patients With Planter Fasciitis
|
N/A | |
Completed |
NCT04967703 -
Physiotherapy Protocols in Treating Plantar Fasciitis
|
N/A | |
Completed |
NCT06446167 -
Comparative Efficacy of Laser, Extracorporeal Shockwave Therapy and Exercise Therapy on Plantar Fasciitis Outcomes
|
N/A |