Effects of Exercise Versus Exercise and Instrument-Assisted Soft Tissue Mobilization for Plantar Fasciopathy Treatment

NCT04162262 | Completed DMC

• 1 other identifier: L19-147
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plantar Fascitis

Keywords

Plantar Fascitis; Instrument-assisted soft tissue mobilization; Stretch and strengthening exercise; Plantar fasciopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Ankle range of motion

  Baseline and weeks 4, 8, and 12

• First metatarsophalangeal range of motions

  Baseline and weeks 4, 8, and 12

• Patient Acceptable Symptom State

  Baseline and weeks 4, 8, and 12. Phone visits at weeks 9, 10, 11.

• Credibility/Expectancy Questionnaire

  Baseline visit

• Visual Analog Scale Pain Score

  Baseline and weeks 4, 8, and 12.

Study Arms (3)

Stretching, Strengthening, and IASTM

EXPERIMENTAL

This group will attend eight weekly sessions, which will include initial screening tests and exercise education on visit 1 and strengthening and stretching exercise progression on visits 1-8. Data measurements will occur at weeks 0, 4, 8, and 12. This group will perform a 5-minute, self-paced warmup on a stationary bicycle followed by a 10-minute IASTM treatment. Test measurements will be performed before and immediately following the warmup and IASTM treatment. They will then perform stretching and strengthening exercises under the supervision of an investigator masked to treatment group weekly for eight visits. Exercise resistance will be increased as needed each week. In addition, participants will perform daily stretching and strengthening exercises at home.

Other: Instrumental-assisted soft tissue mobilization (IASTM); Other: High-Load Strength Training; Other: Plantar Flexor and Gastrocnemius Stretching

Strengthening and Stretching

ACTIVE COMPARATOR

This group will attend eight weekly sessions, which will include initial screening tests and exercise education on visit 1 and strengthening and stretching exercise progression on visits 1-8. Data measurements will occur at weeks 0, 4, 8, and 12. To equalize visit time with the Stretching, Strengthening, and IASTM group, subjects will perform 15 minutes of self-paced bicycle riding at the beginning of each session. They will then perform stretching and strengthening exercises under the supervision of an investigator masked to treatment group weekly for eight visits. Exercise resistance will be increased as needed each week. In addition, participants will perform daily stretching and strengthening exercises at home.

Other: High-Load Strength Training; Other: Plantar Flexor and Gastrocnemius Stretching

Pain-free Comparison Group

OTHER

The third group is a pain-free comparison group. This group will come to the laboratory once. They will perform a 5-minute, self-paced warmup on a stationary bicycle followed by a 10-minute IASTM treatment. Test measurements will be performed before and immediately following the warmup and IASTM treatment. These measurements will be compared to the same measures from the Stretching, Strengthening, and IASTM group to examine outcome measure differences in those with and without plantar fasciopathy following a single IASTM treatment.

Other: Instrumental-assisted soft tissue mobilization (IASTM)

Interventions

Instrumental-assisted soft tissue mobilization (IASTM) OTHER

Instrumental-assisted soft tissue mobilization (IASTM) will consist of treatment focused on the plantar surfaces of foot, posterior heel, and lower leg. The IASTM will be implemented using Graston Technique Instruments by clinicians trained and certified in the technique. Each 10-minute treatment will consist of two phases: 1) six-minute static phase, which includes tissue status screening and soft tissue mobilization, and 2) four-minute dynamic tissue mobilization phase. The treatment will focus on the web spaces of each toe plantarly, the metatarsal heads, the spaces between metatarsals, the medial and lateral plantar fascia borders, plantar fascia proximal origin, the heel, and the lower leg muscle groups. The targeted soft tissues are the plantar fascia, ankle plantar flexors, heel fat pad, Achilles tendon, and the gastrocnemius-soleus complex.

Pain-free Comparison Group; Stretching, Strengthening, and IASTM

High-Load Strength Training OTHER

Participants will perform a heel raise exercise used by Rathleff et al (2015). The exercise will be performed twice daily. While standing with the forefoot on a step, the toes will rest on a partially folded towel, placing them in a maximally dorsiflexed position. The exercise will consist of a maximum ankle plantar flexion followed by maximal dorsiflexion. The concentric plantar flexion and eccentric lowering phases will be 3 seconds, with a 2 second isometric pause in between. The exercise will be performed unilaterally if tolerated by the subject. Otherwise, a bilateral calf raise will be performed until the subject is able to perform the unilateral version. The exercise will be performed every other day and progressed throughout the trial as described by Rathleff and colleagues.

Strengthening and Stretching; Stretching, Strengthening, and IASTM

Plantar Flexor and Gastrocnemius Stretching OTHER

For the plantar flexor stretch (DiGiovanni et al, 2006), subjects will sit and cross the affected leg over the contralateral leg. Placing the affected side fingers on the plantar toes, distal to the metatarsophalangeal joints, they will passively dorsiflex the toes until they feel stretching in the arch of the foot. Subjects will be instructed to hold this stretch for 10 seconds and repeat it 10 times. The gastrocnemius stretch will be performed in supine with a towel placed around the distal foot and the foot actively inverted. With the knee extended, the subject will flex the hip while passively dorsiflexing the foot using the towel. This stretch will be held for 30 seconds and repeated 3 times. Subjects will be asked to perform both stretches three times each day.

Strengthening and Stretching; Stretching, Strengthening, and IASTM

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• age and BMI matched with Group 2 subjects
• no history or symptoms of plantar heel pain in the past 12 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Study Officials

• Troy Hooper, PhD

  Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Random group allocation into Groups 1 and 2 will be performed using a 1:1 allocation ratio with permuted block sizes of 2 to 6. The investigators responsible for the weekly progression of the stretching and strengthening exercise protocol and the outcome assessor will be masked to the participants' assigned groups. The investigators providing instrument-assisted soft tissue mobilization will not be blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is divided into two parts. Part I is a parallel-group, pre-test post-test randomized controlled superiority trial comparing the effects of stretching and strengthening exercises (SS) (Group 1) versus SS plus IASTM (SS+IASTM, Group 2) in subjects with PF. Outcomes will be assessed by a blinded investigator after one visit and 4, 8, and 12 weeks of treatment. Part II is a pre-test, posttest comparison of the short-term effects of IASTM on PF (Group 2) and control (Group 3) groups.

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 14, 2019
• Study Start: October 24, 2019
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

US (1)