Radial vs Focused Shockwave Therapy for Plantar Fasciitis
A Randomised Controlled Trial Comparing Radial Versus Focused Extracorporeal Shockwave Therapy for Chronic Plantar Fasciitis
The goal of this clinical trial is to learn whether focused extracorporeal shockwave therapy (ESWT) provides better outcomes than radial ESWT for adults with plantar fasciitis. It will also learn about the safety and tolerability of both treatments.
The main questions it aims to answer are:
- Does focused ESWT lead to greater improvement in heel pain than radial ESWT?
- Does focused ESWT improve foot function more than radial ESWT?
- Do participants experience less discomfort during focused ESWT compared with radial ESWT?
- What medical problems or side effects occur with either treatment?
Researchers will compare focused ESWT to radial ESWT to see whether one treatment offers better clinical outcomes or is better tolerated.
Participants will:
- Receive three shockwave treatment sessions (radial or focused), one week apart
- Attend clinic follow-up assessments at 6 weeks, 12 weeks, 6 months, and 12 months
- Complete questionnaires about heel pain and foot function Keep a diary of symptoms, daily pain levels, activity limitations, and any use of pain medication
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：DR Mukhey
- 電話番号：020 8510 5555
- メール：dev.mukhey@nhs.net
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
aged 18 years or older; 2. chronic plantar heel pain for at least 3 months; 3. clinical presentation consistent with plantar fasciitis / plantar fasciopathy; 4. baseline average heel pain of at least 4/10 in at least one heel proposed for study treatment; 5. imaging findings supportive of plantar fasciitis / plantar fasciopathy on either:
- ultrasound scan (USS); or
- magnetic resonance imaging (MRI); 6. able to understand the study and provide written informed consent; 7. sufficient spoken and written English to understand the study information and complete the planned questionnaires and telephone follow-up assessments
Exclusion Criteria:
Participants will be excluded for any of the following:
- previous ESWT to the affected study foot;
- corticosteroid injection to the affected region within the preceding 3 months;
- previous plantar fascia surgery;
- an alternative diagnosis considered to be the principal cause of the heel pain;
- current or suspected calcaneal or other relevant stress fracture;
- relevant inflammatory arthropathy;
- pregnancy;
- recognised contraindication to ESWT;
- inability to provide informed consent;
- insufficient spoken or written English to understand the study information or complete the planned study procedures where appropriately translated materials and interpreter-supported longitudinal follow-up are unavailable;
- any other clinical factor considered by the investigator to make participation inappropriate or unsafe
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Random allocation to focused ESWT
|
Patients will be randomly allocated to focused shockwave therapy.
The settings with regards to the waves will be pre-determined and will be the normal setting usually used by the department They will have one session every week for 3 weeks We will chase them up with outcome at 6 weeks, 12 weeks, 6 months and 12months.
|
|
アクティブコンパレータ：Random allocation to radial ESWT
|
Patients will be randomly allocated to radial shockwave therapy The setting for the shockwave will be pre-determined as advised by the literature and manufacturers of the device They will have one session every week for 3 weeks We will chase them up with outcome at 6 weeks, 12 weeks, 6 months and 12months.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Average Heel pain at 12 weeks using a numerical rating scale ranging from 0 - 10
時間枠：12 weeks
|
To compare the clinical effectiveness of radial versus focused Extracorporeal shockwave therapy (ESWT) for chronic plantar heel pain by assessing the difference between treatment groups in average heel pain at 12 weeks, adjusted for baseline pain. The numerical rating scale ranges from 0 - 10 with 10 being a worse outcome |
12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To compare the effect of radial and focused shockwave therapy on foot related function using the modified Foot Function Index (FFI) questionnaire
時間枠：12 months
|
The modified foot function index is a 23 item questionnaire with a 0 - 10 numerical scale response. Higher scoring tends to indicate worse outcome. This questionnaire will be done at baseline, 6 weeks, 12 weeks, 6 months and 12 months |
12 months
|
|
Comparing first step heel pain after radial vs focused shockwave therpay using a numerical rating scale from 0 - 10
時間枠：12 months
|
This will be recorded at baseline, 6 weeks, 12 weeks, 6 months and 12 months.
A higher score indicates a worse outcome
|
12 months
|
|
To compare procedural treatment discomfort after radial vs focused shockwave therapy using a numerical rating scale (ranging 0-10)
時間枠：3 weeks
|
This will be recorded after each treatment session.
There are 3 treatment session in total happening in 3 consecutive weeks, once a week A higher score indicates a worse outcome
|
3 weeks
|
|
Patient-reported global improvement following radial vs focused shockwave therapy using a Likert scale
時間枠：12 months
|
This will be recorded at 6 weeks, 12 weeks, 6 months and 12 months. The likert scale is as follows: Compared with before shockwave treatment, how is your heel pain now? Much worse Worse no change Better Much better |
12 months
|
|
To compare patient satisfaction after undergoing radial vs shockwave therapy using a likert scale
時間枠：12 months
|
Patient satisfaction will be recorded at 12 weeks, 6 months and 12months using a Likert scale in the following format How satisfied are you in the outcome of your treatment?
Very dissatisfied Dissatisfied Neutral satisfied Very satisfied
|
12 months
|
|
To compare willingness to undergo the same treatment after undergoing radial vs shockwave therapy using a qualitative question
時間枠：12 months
|
This will be recorded at baseline 12 weeks, 6 months and 12 months using the following template; If you were int he same situation again, would you choose to have this treatment Yes No Unsure
|
12 months
|
|
Comparing treatment related adverse events after radial vs focused shockwave therapy using a qualitative question
時間枠：12 months
|
This will be recorded at 6 weeks, 12 weeks, 6 months and 12 months.
The question template is as follows; Adverse event since the previous study contact None Bruising New neurological symptoms Pain flare lasting >48hours Skin irritation Others (please elaborate)
|
12 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。