Effectiveness of Manual Therapy Combined With Standard Treatment in the Management of Plantar Fasciitis

NCT01439932 | Completed

• 2 other identifiers: MMC11XXX-XXKCTILPF-001-ISR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Plantar fasciitis (PF) is a common problem that tends to attack about 10% of the population during life. This is a degenerative condition of the plantar fascia at its insertion at the bottom of the heel. Pain appears mainly on the first steps in the morning or after prolonged lack of weight bearing. The pain intensity can be very high and this can cause functional limitations and reduce quality of life. Despite the high prevalence of the PF, treatment is controversial and not supported by extensive research. Review of the previous studies on various treatments, mentioned steroid injections, shock waves, night splint, orthotics, heel padding and stretching exercises. Limitation of ankle dorsi flexion is a common finding and thought to be a contributing factor to the development of pathology. So far, this issue had been addressed mainly by soft tissue therapy techniques to improve ankle range of motion in patients with PF. Only one study (Joshua et al 2009) evaluated the effect of ankle joint mobilizations of PF. However, in this study mobilizations were part of complex therapy and therefore the effect of treatment cannot be attributed solely to them. The purpose of this study is to evaluate the effectiveness of ankle and mid-foot joints mobilization on pain and function of patients with PF. The hypothesis is that manual mobilizations of ankle and midfoot joints in addition to conventional physical therapy will improve pain and function significantly more than conventional treatment, in patients with PF. Methods: 50 patients, age 18-75 with a diagnosis of PF that meet the inclusion criteria will be recruited and randomly divided into two groups. Both groups will receive commonly accepted physical therapy treatment that includes stretching exercise of the plantar fascia and triceps surae muscles and ultrasound therapy at the site of symptoms. The study group will receive in addition manual mobilizations to the ankle and midfoot joints. The procedures will take place at the physiotherapy clinic Bat-Yamon of General Health Services and will last four weeks, twice a week.

Conditions

Plantar Calcaneal Spur; Fasciitis, Plantar

Keywords

plantar fasciitis; heel pain; manual treatment; dorsi flexion

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale 0-10

  The participant will rate his pain intensity at first step in the morning on a scale of numbers between 0-10 when 0 means "no pain" and 10 means "very severe pain". NPRS is a valid and reliable tool for assessment of pain intensity and is a common tool in studies on PF.

  one year and two months

Study Arms (1)

ankle mobilization for pain release

EXPERIMENTAL

stretching exercise for the plantar fascia and triceps surae muscles three times a day throughout the study period. During each visit the exercise performance will be checked by the therapist. In addition, participants from both groups will get ultra sound therapy in frequency of 1 MHz, power of 1.5 watts per centimeter-squared, pulses of 50% for 5 minutes. The study group will receive the same treatment and a number of manual techniques that include antero-posterior (AP) mobilization for talocrural joint in two variations (weight baring and non-weight baring) to improve the range of dorsi flexion, subtalar joint mobilization to improve range of eversion and mid-tarsal mobilization to improve pronation / supination of the forefoot. Each technique will be carried out for 1 to 1.5 minutes for a total of 5 minutes of manual treatment. All patients will receive information and guidance to practice at home.

Device: algometer

Interventions

algometer DEVICE

Pressure algometer (Algometry) - This is an instrument that measures pain threshold (the minimum pressure required to produce pain). The instrument consists of a flat disk size centimeter square attached to pressure transducer and measuring electrodes. The disk is placed vertically on the point of pain and therapist increases the intensity of the pressure until initial pain appears (when sense of pressure becomes sense of pain.) Score is determined by average of three repeated measurements with 30 seconds break between each. The algometer allows an objective assessment of pain in addition to LEFS score which is a subjective tool. The algometer test was found to be valid and reliable in repeated measurements (interrater, intrarater) by Andrew A. Fischerin 1987 with healthy people \[Andrew 1987\]. In another study high reliability was found for averaging between three repeated tests: ICC = 0.91 (CI 0.82; 0.97 95%). \[Linda et al 2007\]

Also known as: SBMEDIC Electronics

ankle mobilization for pain release

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75
• Pain allocated at the bottom of heel and produced by pressure
• Pain in the morning at first steps or after prolonged non-weight bearing
• NPRS morning pain score of 3 or higher

You may not qualify if:

• Tumors
• Prolonged use of steroids
• Fracture below knee during the last year
• Prior foot surgeries
• A positive diagnosis of Tarsal Tunnel Syndrome (TTS) / Fat Pad Syndrome
• Pregnancy
• Lack of availability in the coming month

Sponsors & Collaborators

• Meir Medical Center: lead
• Clalit Health Services: collaborator

Study Sites (1)

Clalit Health Services, Tel-Aviv district, Bat Yamon

Bat Yam, Israel

Location

Related Publications (1)

• Shashua A, Flechter S, Avidan L, Ofir D, Melayev A, Kalichman L. The effect of additional ankle and midfoot mobilizations on plantar fasciitis: a randomized controlled trial. J Orthop Sports Phys Ther. 2015 Apr;45(4):265-72. doi: 10.2519/jospt.2015.5155. Epub 2015 Mar 4.

  PMID: 25739844 DERIVED

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Anat Shashua, BPT

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 23, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 20, 2013

Record last verified: 2011-09

Locations

IL (1)