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

NCT06706531 | Recruiting

• 1 other identifier: FUI/CTR/2024/53
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plantar Fascitis

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Standard treatment + Sham Dry needling

ACTIVE COMPARATOR

Participants will receive standard treatment of plantar facitis along with sham dry needling

Procedure: Standard treatment; Procedure: Sham Dry needling

Standard treatment + Dry needling

EXPERIMENTAL

Participants will receive standard treatment of plantar facitis along with dry needling

Procedure: Standard treatment; Procedure: Dry needling

Interventions

Standard treatment PROCEDURE

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

Standard treatment + Dry needling; Standard treatment + Sham Dry needling

Sham Dry needling PROCEDURE

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.

Standard treatment + Sham Dry needling

Dry needling PROCEDURE

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.

Standard treatment + Dry needling

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Areeba Michelle, MS-MSKPT*

CONTACT

0334-8546616; aribaa.michelle@gmail.com

Study Design

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

Model Details: Randomized control trial

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

PA (1)