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临床试验/NCT07079566
NCT07079566尚未招募不适用

Effect of Primal Reflex Release Technique on Pain and Function in Plantar Fasciitis Patients

Riphah International University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
32
试验地点
1
主要终点
Change in Pain Intensity using Numeric Pain Rating Scale

研究概览

简要总结

The plantar fascia at the foot bottom causes pain and inflammation which affects this thick tissue that runs from heel bone to toe. This condition stands as the main source of heel pain and produces intense stabbing sensations which become noticeable in the morning and during periods of rest. The foot pain generally reduces when a foot becomes active but it often resurfaces after standing or being active for prolonged periods of time(1).

Plantar fasciitis occurs as a frequent problem which affects 10% of people worldwide during their lifespans. Annual plantar fasciitis cases in adults reach 1% within the United States while medical care is provided to over 2 million people annually. Research shows that plantar fasciitis affects a similar proportion of people in the United Kingdom during their lifetime at about 10%(2). The prevalence rate for plantar fasciitis in Pakistan remains unclear because studies show that 4.72% of housewives in Lahore experience the condition. Plantar fasciitis represents a widespread foot condition worldwide since it affects numerous population groups based on these statistical reports(3).

The main symptom of plantar fasciitis manifests as heel pain that feels either sharp and burning and stabbing. Heel pain reaches its highest intensity during the morning after a person wakes up because of the initial foot movements. Heel pain intensifies when maintaining a resting position but subsides as the affected person becomes active. The medical condition becomes worse due to high amounts of physical activity that results in daily foot pain(4).

Many patients report foot sensitivity combined with swellings that develop either in the heel zone or beneath the foot arch. The heel area tends to experience pain PRT establishes an efficient pain management strategy through its ability to treat nervous system dysfunctions which generate chronic pain and inflammatory conditions. PRRT improves health outcomes along with reducing treatment duration while it substantially enhances the life quality of people who experience prolonged pain. The body's natural pain relievers activate through non-invasive movements in Primal Reflex Release Technique which makes this method important for treating plantar fascitis.Through reflex activation PRT activates natural pain-relieving mechanisms of the brain thus leading to substantial pain reduction and improved inflammation levels. The direct intervention on pain-causing nerve dysfunctions resulting from chronic pain through PRT activates healthy nervous system operations(25).

The best results from PRT emerge when patients use it together with physical therapy along with stretching and strengthening therapeutic exercises. The therapy presents both gentle nature and noninvasive methods with combined benefits of using little to no medical drugs or special devices. The therapy serves alongside multiple therapeutic approaches for treating enduring pain issues and inflammatory conditions of the back, neck, and head along with fibromyalgia and arthritis and tendinitis and plantar fasciitis. The therapy provides therapeutic benefits in neurological medical fields which assist patients with sciatica and neuropathy complications and Parkinson's disease conditions.

详细描述

The Primal Reflex Release Technique (PRRT) was used to treat Medial Tibial Stress Syndrome (MTSS) in NCAA Division I cheerleaders. Three male and two female participants, with a mean age of 20 ± 1.4 years, who had been diagnosed with Type II MTSS, received PRRT treatment. The research indicated both immediate pain relief after a single treatment session and functional enhancement after an average of 4.2 (± 0.84) sessions over 15.4 (± 5.86) days, all without any imposed training pauses. Patient outcomes from PRRT showed lasting improvements during both the initial follow-up and the two-week check-up, indicating the effectiveness of this method for MTSS patients. The study suggests that PRRT shows promise as a non-invasive therapy for the effective management of stress-related tibial pain in athletic populations (29).

Current literature on plantar fasciitis syndrome (PFS) treatment using manual physiotherapy is limited. Therefore, a randomized controlled trial was conducted by Khammas et al. (2024) to evaluate the efficacy of manual physiotherapy in altering plantar fascia morphology, including changes in the thicknesses of the central fascial portion (CFP) and the key fascial portion (KFP), pain levels, and foot function in PFS patients. The participants were divided into three groups: Group A (40 PFS patients receiving manual physiotherapy), Group B (42 PFS patients receiving no intervention), and Group C (40 healthy controls matched for age, gender, and BMI). Results showed a significant increase in plantar fascia thickness in Groups A and B (P < 0.001). However, Group A showed significant improvements in plantar fascia thickness, echogenicity, CFP thickness (P < 0.001), pain reduction, and functional performance-particularly in acute cases of PFS (30).

The foot and ankle play essential roles in locomotion, functioning as shock absorbers, allowing adaptation to uneven surfaces, and providing stability. Dysfunction in this region can contribute to issues involving the knee, hip, spine, and can lead to recurrent stress fractures, plantar fasciitis, and tibial stress syndromes. These dysfunctions need to be addressed through biomechanical and neuromuscular reflexive approaches. The Primal Reflex Release Technique (PRRT) is of interest due to its influence on involuntary reflexive responses. PRRT helps reset dysfunctional neuromuscular patterns to alleviate pain and improve function in conditions such as plantar fasciitis and MTSS, making it a promising, non-invasive intervention for both athletes and chronic sufferers of foot and lower limb pain (31).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

In this randomized controlled trial, a single-masked (assessor-blinded) design was used. Participants were randomly assigned to either the experimental group receiving the Primal Reflex Release Technique (PRRT) or the control group receiving conventional treatment. Due to the hands-on and physical nature of the PRRT intervention, it was not feasible to blind participants or treating therapists. However, to reduce the risk of detection and measurement bias, the outcome assessors responsible for evaluating the pre- and post-intervention scores were blinded to the group allocation. These assessors collected data using validated outcome measures, including the Numeric Pain Rating Scale (NPRS) and Foot Function Index (FFI). They were not involved in the treatment sessions and were unaware of which participants received which intervention. so it means thatthis blinding procedure was designed to maintain objectivity in data collection and enhance the internal validity of the study results.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18-40 years and of both genders.
  • •Diagnosed with Plantar Fasciitis by a healthcare professional
  • •Experiencing heel pain or pain at the bottom of the foot for at least 3 months or more than 3 months
  • •Patient with acute or chronic planter fasciitis Positive windless test.
  • •Pain with walking or dorsiflexion of the toes, especially in the morning Willing to adhere to the study protocol

排除标准

  • •Participants were excluded if they have any of the following: Previous surgery for Plantar Fasciitis
  • •Systemic inflammatory conditions (e.g., rheumatoid arthritis) Pregnancy
  • •Neurological disorders affecting the lower limbs Other foot pathologies (e.g., tarsal tunnel syndrome)

研究组 & 干预措施

Primal Reflex Release Technique (PRRT) Group A

Experimental

Participants in this group will receive the Primal Reflex Release Technique (PRRT), a hands-on manual therapy based on the principle of modulating overactive primal reflexes believed to contribute to chronic musculoskeletal pain and dysfunction. The intervention is designed to target reflexive neuromuscular responses to reduce muscle guarding and pain. The PRRT sessions will be administered by a trained physiotherapist over a 3-week period, with three sessions per week, totaling nine sessions. Each session will last approximately 20-30 minutes. The technique includes procedures like sternocleidomastoid release, startle reflex inhibition, and skin stretch methods. The aim is to reduce plantar fascia tension by addressing upstream reflexive tension patterns. All participants will be assessed pre- and post-intervention using the Numeric Pain Rating Scale and Foot Function Index to evaluate changes in pain and functional ability.

干预措施: Primal Reflex Release Technique (PRRT)he Primal Reflex Release Technique (PRRT) is a hands-on, non-invasive therapeutic approach designed to deactivate overactive protective reflexes believed to contr (Behavioral)

Conventional Physiotherapy Group B

Active Comparator

Participants in this group will receive conventional physiotherapy treatment commonly used for plantar fasciitis management. This includes static stretching of the plantar fascia and Achilles tendon, strengthening exercises for intrinsic foot muscles, heel cord stretches, ice therapy, footwear advice, and patient education. The treatment will also be provided over 3 weeks, with sessions scheduled three times per week for a total of nine sessions, each lasting 20-30 minutes. This standard care group serves as the control arm to evaluate the comparative effectiveness of the Primal Reflex Release Technique. All participants in this group will undergo pre- and post-intervention assessment using the Numeric Pain Rating Scale (NPRS) and the Foot Function Index (FFI) to measure changes in pain levels and foot-related functional limitations.

干预措施: Conventional Physiotherapy Treatment This reflects the standard care or routine treatment used as a comparison in your randomized controlled trial on plantar fasciitis. Let me know if your control gr (Behavioral)

结局指标

主要结局

Change in Pain Intensity using Numeric Pain Rating Scale

时间窗: Baseline and after 3 weeks of intervention

The Numeric Pain Rating Scale (NPRS) is an 11-point scale used to assess the intensity of pain. Patients rate their current pain from 0 (no pain) to 10 (worst imaginable pain). This study assesses change in NPRS scores from baseline to post-intervention. The tool is highly reliable (r = 0.95-0.98) and valid (r = 0.85-0.95) for clinical use.

次要结局

  • Change in Foot Function using Foot Function Index (FFI)(Baseline and after 3 weeks of intervention ❗️Summary of Fixes: All repeated NPRS entries were consolidated into one primary measure. The "Time Frame: 3" issue was corrected by clearly stating "Baseline and after 3 weeks of intervention". The secondary)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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