The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome
The goal of this randomized clinical trial is to evaluate the effects of high-intensity laser therapy on pain intensity, quality of life, hip range of motion, and global rating of change in individuals with femoroacetabular impingement syndrome (FAIS).
The main questions it aims to answer are: Does high-intensity laser therapy improve pain intensity, quality of life, hip range of motion, and global rating of change in patients with Femoroacetabular Impingement Syndrome? Does adding high-intensity laser therapy to exercise therapy produce greater improvements in pain intensity, quality of life, hip range of motion, and global rating of change in patients with Femoroacetabular Impingement Syndrome?
Participants will be randomly assigned to one of two groups for comparison. The first group (control group) will receive a standardized exercise therapy program consistent with routine exercises for femoroacetabular impingement syndrome, along with sham high-intensity laser therapy. The second group (experimental group) will receive the same standardized exercise therapy program in addition to active high-intensity laser therapy.
調査の概要
状態
詳細な説明
High-intensity laser therapy (HILT) is a non-invasive therapeutic modality that uses high-intensity laser energy to penetrate tissues and promote pain relief and tissue healing. Emerging evidence suggests that HILT may be effective in reducing musculoskeletal pain and improving joint range of motion in individuals with shoulder and knee conditions. However, evidence regarding its effectiveness in individuals with femoroacetabular impingement syndrome (FAIS) remains limited. Thus, the investigators hypothesized that HILT would improve pain intensity, quality of life, hip range of motion, and global rating of change in individuals with FAIS.
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：Ahmad M. El Melhat, PhD
- 電話番号：+20 11 12595022
- メール：ahmed.elmelhat@cu.edu.eg
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults aged 20-45 years
- Anterior hip or groin pain with an average intensity of at least 3/10 persisting for a minimum of six weeks
- Pain aggravated by prolonged sitting or hip movements involving impingement positions
- Positive flexion, adduction, and internal rotation (FADIR) test
- Radiographic evidence of cam morphology, with an alpha angle ≥60° in at least one hip
Exclusion Criteria:
- Physiotherapist-led treatment or intra-articular hip injection within the previous three months
- Previous hip, pelvic, or spinal surgery
- Planned lower-limb surgery within the following 12 months
- Moderate-to-severe hip osteoarthritis (Kellgren-Lawrence grade ≥2)
- Neurological, systemic arthritic, or other musculoskeletal conditions primarily responsible for hip pain
- Inability to complete the assessments or commit to the six-month treatment and follow-up period
- Contraindications to radiographic imaging
- Pregnancy at enrollment or during the trial
- Contraindications to high-intensity laser therapy (HILT), including known or suspected malignancy in the treatment area, photosensitivity or use of photosensitizing medications, active deep vein thrombosis, and impaired sensation in the treatment area
- Inability to comply with laser safety precautions, including the use of protective eyewear
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：High Intensity Laser Therapy
This group will receive High Intensity Laser Therapy in addition to standard exercise for FAIS |
Participants will receive HILT three times a week for six weeks. The standard exercise program will be performed three times a week for 6 weeks. |
|
偽コンパレータ：Sham High Intensity Laser Therapy
This group will receive Sham High Intensity Laser Therapy in addition to standard exercise for FAIS. |
The standard exercise program will be performed three times a week for 6 weeks. Participants will receive Sham HILT three times a week for six weeks |
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 |
|---|---|---|
|
Pain intensity
時間枠：Pre-intervention,post intervention (week 6), and week 12 as follow up.
|
Pain intensity will be measured using the Numeric Pain Rating Scale ( NPRS). Scores range from 0 (no pain) to 10 (worst pain). |
Pre-intervention,post intervention (week 6), and week 12 as follow up.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hip range of motion
時間枠：Pre-intervention,post intervention (week 6), and week 12 as follow up.
|
Hip range of motion will be measured using a goniometer , with measurements recorded in degrees. |
Pre-intervention,post intervention (week 6), and week 12 as follow up.
|
|
Hip-related quality of life
時間枠：Pre-intervention,post intervention (week 6), and week 12 as follow up.
|
The hip-related quality of life will be measured using the International Hip Outcome Tool (iHOT-33). Scores range from 0 (worst possible hip-related quality of life) to 100 (best possible hip-related quality of life). |
Pre-intervention,post intervention (week 6), and week 12 as follow up.
|
|
Perceived rate of change
時間枠：Pre-intervention,post intervention (week 6), and week 12 as follow up.
|
The perceived rate of change will be measured using the Global Rating of Change (GROC). Scores range from negative values (worsening) to 0 (no change) and positive values (improvement). |
Pre-intervention,post intervention (week 6), and week 12 as follow up.
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Ahmad El Melhat, PhD、Cairo University
出版物と役立つリンク
一般刊行物
- Aoyama M, Ohnishi Y, Utsunomiya H, Kanezaki S, Takeuchi H, Watanuki M, Matsuda DK, Uchida S. A Prospective, Randomized, Controlled Trial Comparing Conservative Treatment With Trunk Stabilization Exercise to Standard Hip Muscle Exercise for Treating Femoroacetabular Impingement: A Pilot Study. Clin J Sport Med. 2019 Jul;29(4):267-275. doi: 10.1097/JSM.0000000000000516.
- Pacheco-Brousseau L, Beaule PE, Carsen S, Wilkin G, Grammatopoulos G, Poitras S. Efficacy of a home-based hip exercise programme for patients with symptomatic cam femoroacetabular impingement: a randomized controlled trial. Bone Jt Open. 2025 Sep 19;6(9):1138-1145. doi: 10.1302/2633-1462.69.BJO-2025-0125.R1.
- Kemp JL, Johnston RTR, Coburn SL, Jones DM, Schache AG, Mentiplay BF, King MG, Scholes MJ, De Oliveira Silva D, Smith A, McPhail SM, Crossley KM. Physiotherapist-led treatment for femoroacetabular impingement syndrome (the PhysioFIRST study): a protocol for a participant and assessor-blinded randomised controlled trial. BMJ Open. 2021 Apr 7;11(4):e041742. doi: 10.1136/bmjopen-2020-041742.
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- High Intensity Laser Therapy
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。