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NCT Number: NCT06706531

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.

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Key information

Conditions

Plantar Fascitis

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

Location status: Recruiting

Location contact

Qurat ul Ain Saeed, MS-OMPT,PHD*

CONTACT

[email protected]

03315562889

About this study

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:

  • Numeric pain rating scale
  • Goniometer
  • 30 meter walk test
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

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.

Primary outcomes

  1. Pain intensity

    Time frame: 3 weeks

    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").

  2. The Foot and Ankle Ability Measure (FAAM)

    Time frame: 3 weeks

    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. Gait speed:

    Time frame: 3 weeks

    Gait speed = Distance (m) / time (s)

  4. Cadence

    Time frame: 3 weeks

    Cadence (steps/min) = steps counted x 60 / time (s)

  5. Cycle length

    Time frame: 3 weeks

    Cycle time (s) = time (s) x 2/steps counted

  6. Stride length

    Time frame: 3 weeks

    SL (m) = speed (m/s) x cycle time (s)

  7. Range of motion

    Time frame: 3 weeks

    Ankle range will be measured with goniometer

Study contacts

Contact information is provided by the study sponsor or research team.

Areeba Michelle, MS-MSKPT*

CONTACT

[email protected]

0334-8546616

Sponsors and collaborators

Lead sponsor

Foundation University Islamabad

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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