Additional Effects of Dry Needling With Conventional Physical Therapy Versus Conventional Physical Therapy in Plantar Fasciitis: a Randomized Control Trial

This study is a randomized controlled trial and the purpose of this study is to determine the effects of dry needling with conventional physical therapy versus conventional physical therapy on gait parameters in plantar fasciitis: a randomized control trial.

Study Overview

• Status: Recruiting
• Conditions: Plantar Fascitis
• Intervention / Treatment: Procedure: Standard treatment; Procedure: Sham Dry needling; Procedure: Dry needling

Detailed Description

The purpose of this study is to determine the effects of dry needling with conventional physical therapy versus conventional physical therapy on gait parameters in plantar fasciitis Outcomes variables of Pain , Ankle ROM, gait parameters and activities of daily living in adults (age : 40-60 years ) will be determined using:

1. Numeric pain rating scale
2. Goniometer
3. 30 meter walk test
4. foot and ankle ability measure FAAM Data will be before and after the intervention protocol for each participant. Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Pre and post intervention scores will be recorded.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Areeba Michelle, MS-MSKPT*; Phone Number: 0334-8546616; Email: aribaa.michelle@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Recruiting
      • Foundation University College of Physical Therapy
      • Contact: Qurat ul Ain Saeed, MS-OMPT,PHD*; Phone Number: 03315562889; Email: quratulain.saeed@fui.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Age 40-60 years
• Both genders
• Plantar heel pain for longer than 3 months
• Pain score at least or less than 8 on the numeric pain (NPRS)
• Clinical diagnosis of unilateral PF in accordance with the clinical practice guidelines from the Orthopaedic Section of the American Physical Therapy Association APTA:
• Plantar medial heel pain: most noticeable with initial steps after a period of inactivity but also worse following prolonged weight bearing
• Heel pain precipitated by a recent increase in weight bearing activity
• Pain with palpation of the proximal insertion of the plantar fascia
• Positive windlass test
• Negative tarsal tunnel tests
• Limited active and passive talocrural joint dorsiflexion range of motion
• Abnormal foot posture index score
• High body mass index in nonathletic individuals

Exclusion criteria:

• Positive ankle drawer tests
• Pregnant womwn, mental illness, immune suppressed patients, thrombocytopenia, anti-coagulant therapy patients and post-mastectomy
• Congenital abnormalities of foot
• A history of surgery to the ankle, foot or lower leg
• Other causes of heel pain (including tarsal tunnel syndrome, calcaneal fracture, ankle or foot instability, arthritis of the foot or ankle, rheumatoid arthritis, spondyloarthropathy, gout,peripheral neuropathy )
• Presented with 2 or more positive neurologic signs consistent with nerve root compression

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard treatment + Sham Dry needling; Participants will receive standard treatment of plantar facitis along with sham dry needling	Procedure: Standard treatment; All participants received up to six treatment sessions at a frequency of twice per week over a 3-week period i.e. ultrasound (0.5 W/cm² of 3 MHz for 5 minutes over plantar aspect of foot), stretching exercises and strengthening exercises. The exercise pro; Procedure: Sham Dry needling; The sham dry needling group will also receive 6 sessions of sham dry needling on soleus, quadratus plantae, flexor digitorum brevis, and abductor halluces muscles for 5 minutes.Sterilized disposable stainless steel acupuncture needles of 0.25mm x 30mm will be used with depth of 20-55mm.The plantar and medial surface of the foot and ankle will be cleaned with alcohol. The sham dry needling will be performed for 5 minutes.
Experimental: Standard treatment + Dry needling; Participants will receive standard treatment of plantar facitis along with dry needling	Procedure: Standard treatment; All participants received up to six treatment sessions at a frequency of twice per week over a 3-week period i.e. ultrasound (0.5 W/cm² of 3 MHz for 5 minutes over plantar aspect of foot), stretching exercises and strengthening exercises. The exercise pro; Procedure: Dry needling; The dry needling group will receive 6 sessions of dry needling using a standardized trigger point protocol on soleus, quadratus plantae, flexor digitorum brevis, and abductor halluces muscles for 5 minutes. Sterilized disposable stainless steel acupuncture needles of 0.25mm x 30mm will be used with depth of 20-55mm. The calf, plantar and medial surface of the foot and ankle will be cleaned with alcohol. Following insertion, needles will be manipulated bi-directionally to elicit a sensation of aching, tingling, deep pressure, heaviness or warmth. The needles will then left in situ for 5 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain will be measured on Numerical Pain rating scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	3 weeks
The Foot and Ankle Ability Measure (FAAM)	It is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments .The response to each item on the ADL subscale is scored from 4 to 0, with 4 being 'no difficulty' and 0 being 'unable to do'	3 weeks
Gait speed:	Gait speed = Distance (m) / time (s)	3 weeks
Cadence	Cadence (steps/min) = steps counted x 60 / time (s)	3 weeks
Cycle length	Cycle time (s) = time (s) x 2/steps counted	3 weeks
Stride length	SL (m) = speed (m/s) x cycle time (s)	3 weeks
Range of motion	Ankle range will be measured with goniometer	3 weeks

Collaborators and Investigators

• Sponsor: Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: FUI/CTR/2024/53

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No