- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07426783
Dry Needling and Fascial Manipulation Techniques in Plantar Fasciitis.
Comparative Effects of Fascial Manipulation and Dry Needling Technique in Management of Chronic Plantar Fasciitis
The goal of this randomized controlled clinical trial is to evaluate whether Fascial Manipulation (FM) or Dry Needling (DN) can effectively reduce pain, improve functional mobility, and enhance range of motion (ROM) in individuals with chronic Plantar Fasciitis (PF) aged 25-45 years
The main questions it aims to answer are:
- Does Fascial Manipulation significantly reduce pain intensity in patients with chronic Plantar Fasciitis?
- Does Dry Needling provide comparable or superior improvements in functional mobility and ankle-foot ROM compared to Fascial Manipulation?
Researchers will compare the Fascial Manipulation group to the Dry Needling group to determine which intervention is more effective in improving pain and functional outcomes in chronic PF.
Participants will:
Receive either Fascial Manipulation or Dry Needling interventions according to their assigned group.
Attend treatment sessions twice a week for six weeks.
Undergo baseline, mid, and post-intervention assessments of pain (VAS-100scale), functional mobility (FFI), diagnostic (PFPS, Windlass, and ankle-foot range of motion (goniometric measurements).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Plantar fasciitis (PF) is one of the most common causes of heel pain, characterized by inflammation and micro tears in the plantar fascia, a thick band of connective tissue that runs along the sole from the heel to the toes. This condition typically results from repetitive stress, excessive foot loading, or biomechanical imbalances, leading to stabbing pain, particularly during the first steps in the morning or after prolonged periods of inactivity. PF is often classified as an overuse injury and is commonly associated with factors such as prolonged standing, high-impact activities, obesity, and improper footwear. Despite being self-limiting in some cases, chronic PF can significantly impact mobility and quality of life, making effective management strategies essential for long-term relief.
Plantar fasciitis (PF) is a leading cause of chronic heel pain, affecting approximately 10% of the population at some point in their lives. It is particularly prevalent among individuals aged 30 to 60 years. It is more commonly observed in women than men, with a female-to-male ratio of nearly 2:1. Professions requiring prolonged standing or repetitive weight-bearing activities, such as nurses, teachers, factory workers, and military personnel, are at higher risk. Additionally, PF is a common overuse injury among athletes, especially runners, whose prevalence ranges from 4% to 22%, depending on the intensity of training and biomechanical factors. Despite the widespread occurrence of PF, managing this condition remains challenging, especially in chronic cases where pain persists for more than six months. Numerous conventional treatments are currently used to treat plantar fasciitis including calf stretching, foot taping, manual therapy (joint mobilization and manipulation; mobilization of soft tissue near sites of nerve entrapment and passive neural mobilization techniques), foot orthosis, oral and injectable anti-inflammatories, and night splints, Surgery is recommended as a last option and is usually done after failure of at least six months of conservative therapy. However, these modalities may be associated with serious side effects and challenges toward an alternative adjunctive treatment are thus demanded. Dry needling are increasingly being used to treat heel pain, as many other musculoskeletal pain.
Fascial manipulation (FM), developed by Luigi Stecco, is a manual therapy technique that focuses on addressing restrictions in the deep fascia to restore normal movement and reduce pain. Fascia, a continuous connective tissue network surrounding muscles and organs, plays a crucial role in movement coordination and force transmission. When fascial densifications or adhesions occur, they can alter biomechanical function and contribute to pain and dysfunction. FM aims to release these fascial restrictions through precise and sustained pressure on specific fascial points, leading to improved proprioception, restored elasticity, and enhanced neuromuscular control. Research has shown that FM can provide significant pain relief and functional improvement in chronic musculoskeletal conditions, making it a promising intervention for PF.
On the other hand, dry needling (DN) is a minimally invasive technique that involves inserting fine monofilament needles into myofascial trigger points (MTrPs) to relieve muscle tension and pain. Unlike acupuncture, which is based on traditional Chinese medicine, DN is rooted in Western medical principles and specifically targets neuromuscular dysfunction. The insertion of needles into hyperirritable muscle spots induces localized twitch responses, which help disrupt the cycle of pain and muscular tightness. Additionally, DN stimulates endorphin release, enhances local blood circulation, and promotes tissue healing. Studies suggest that DN is effective in reducing pain intensity and improving mobility in patients with chronic PF, particularly when combined with other therapeutic interventions such as stretching and manual therapy.
The aim of this study is to compare the effectiveness of Fascial Manipulation (FM) and Dry Needling (DN) combined with conventional therapy in the management of chronic Plantar Fasciitis (PF). By evaluating pain relief, functional improvement, and long-term treatment outcomes, this research seeks to determine which technique offers superior therapeutic benefits and whether a combined approach enhances patient recovery. Additionally, the study aims to address the existing research gap by providing evidence-based insights into the comparative efficacy of these two interventions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
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Rawalpindi, Punjab Province, Pakistan
- Railway General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants falling in this category would be recruited into the study.
- Females aged 25-45 years with chronic heel pain with symptoms persisting for more than one month.
- Having a heel pain on the first step during the last week with the rate of at least 40 mm on visual analogue scale.
- Presence of morning heel pain, tenderness at the medial calcaneal tubercle, and heel spur, or pain exacerbated by prolonged standing, walking, or dorsiflexion
- Patients accepting to discontinue analgesics, non-steroidal anti-inflammatory medications and oral/topical paracetamol during the study period.
- Patients diagnosed with plantar fasciitis using Plantar fasciitis questionnaire.
Exclusion Criteria:
Participants fall in this category would be excluded of the study.
- History of foot or ankle fractures, surgeries, or inflammatory conditions like RA.
- Presence of any neurological disorders affecting gait.
- Participants with diagnosed tendinopathies, including Achilles tendinopathy, posterior tibial tendinopathy, etc. will be excluded from the study to ensure the specificity of plantar fasciitis.
- Participants with metabolic disorders (e.g., osteomalacia, osteoporosis, rheumatoid arthritis, diabetes) affecting bone and soft tissue integrity will be excluded to prevent confounding effects on pain, healing, and treatment outcomes
- Active infections, open wounds, or skin conditions at the treatment site.
- Diabetic neuropathy or vascular insufficiencies that may affect healing and sensations.
- Patients with bleeding disorders like hemophilia and those on anti-coagulant therapy.
- Patients with hypersensitivity reactions to needles or specific metals used in needles.
- Patients with needle phobia.
- Patients with history of epilepsy or seizures.
- Use of corticosteroid injections, shockwave therapy, or other invasive treatments for PF in the last 3 months.
- Participation in another clinical trial or conflicting therapy during the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fascial Manipulation + conventional PT
FMT: Fascial Manipulation (FM) targets myofascial dysfunction by applying deep manual pressure to densified fascial layers involved in chronic pain and mobility restrictions. The following techniques will be used:
Total duration is 2 sessions per week for 6 consecutive weeks. |
Fascial Manipulation (FM) targets myofascial dysfunction by applying deep manual pressure to densified fascial layers involved in chronic pain and mobility restrictions. The following techniques will be used:
Total duration is 2 sessions per week for 6 consecutive weeks |
|
Experimental: Dry needling + Conventional PT
Dry Needling: Dry needling (DN) is an effective technique for releasing myofascial trigger points, reducing pain and improving muscle function. The following protocol will be used: The targeted areas are: (plantar fascia, gastrocnemius (medial & lateral heads), soleus, tibialis posterior) Sterile monofilament needles (0.30 mm x 30 mm) will be used. The needle will be inserted perpendicularly into trigger points by Piston (rapid in and out technique). Duration will be done twice a week for 6 weeks. Conventional Exercises: Ice therapy after dry needling to overcome soreness, stretching Exercises (Plantar Fascia Stretch, gastrocnemius stretch, soleus Stretch, towel stretch) and strengthening Exercises (Toe curls, resisted ankle dorsiflexion with resistance band, heel raises). Total duration is 2 sessions per week for 6 consecutive weeks |
Dry Needling: Dry needling (DN) is an effective technique for releasing myofascial trigger points, reducing pain and improving muscle function. The following protocol will be used: The targeted areas are: (plantar fascia, gastrocnemius (medial & lateral heads), soleus, tibialis posterior) Sterile monofilament needles (0.30 mm x 30 mm) will be used. The needle will be inserted perpendicularly into trigger points by Piston (rapid in and out technique). Duration will be done twice a week for 6 weeks. Conventional Exercises: Ice therapy after dry needling to overcome soreness, stretching Exercises (Plantar Fascia Stretch, gastrocnemius stretch, soleus Stretch, towel stretch) and strengthening Exercises (Toe curls, resisted ankle dorsiflexion with resistance band, heel raises). Total duration is 2 sessions per week for 6 consecutive weeks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Foot Function Index (FFI):
Time Frame: 3 weeks
|
It is a self-reported questionnaire designed to assess pain, disability, and activity limitation in individuals with foot disorders.
It consists of 23 items divided into three subscales: pain, disability, and activity restriction
|
3 weeks
|
|
Visual Analog Scale (VAS 100):
Time Frame: 3 weeks
|
To assess pain intensity, a 100 mm horizontal Visual Analog Scale (VAS) will be employed, where patients mark their pain level along a continuum ranging from 0 mm (no pain) to 100 mm (worst possible pain). Patient will be asked to verbally report the pain score. |
3 weeks
|
|
Plantar Fasciitis Pain/Disability Scale (PFPS)
Time Frame: 3 weeks
|
The Plantar Fasciitis Pain/Disability Scale (PFPS) is a specialized tool designed to assess pain and functional limitations specific to plantar fasciitis.
It includes questions related to pain intensity, duration, frequency, and the impact on daily activities, aiming to differentiate plantar fasciitis from other heel pain conditions
|
3 weeks
|
|
Goniometry
Time Frame: 3 weeks
|
A goniometer will be used to measure the range of motion (ROM) of the ankle joint and 1st MTP joint
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Windlass test
Time Frame: 3 weeks
|
The Windlass Test is a clinical assessment tool used to evaluate the integrity of the plantar fascia and assist in diagnosing plantar fasciitis.
This test involves dorsiflexing the great toe to stretch the plantar fascia, observing for pain reproduction or palpable tightening
|
3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hafsa Siddiqui, MSOMPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Noor Fatima MS-PT/02215
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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