TECAR Therapy in Chronic Back Pain
An Investigation Into the Short-term Effects of Capacitive and Resistive Electrical Transfer Therapy Alone Versus Combined With Electrical Stimulation in Chronic Low Back Pain.
The goal of this clinical trial is to learn whether adding high-intensity electromyostimulation (Hi-EMS) to capacitive and resistive electric transfer (TECAR) therapy improves pain and functional performance in adults with chronic nonspecific low back pain. The main questions it aims to answer are:
- Does adding Hi-EMS to TECAR therapy reduce low back pain at rest?
- Does adding Hi-EMS reduce pain during the Five-Times-Sit-to-Stand Test?
- Does adding Hi-EMS improve pressure pain threshold and performance on the - Five-Times-Sit-to-Stand Test?
Researchers will compare TECAR therapy delivered with Hi-EMS to TECAR therapy delivered without Hi-EMS.
Participants will:
- Receive both treatment conditions in a randomized order
- Wait one week between treatment sessions
- Receive 10 minutes of capacitive electrical transfer followed by 10 minutes of resistive electrical transfer during each session
- Receive Hi-EMS during the 10-minute resistive electrical transfer phase in one of the sessions
- Complete pain, pressure pain threshold, and functional performance assessments immediately before and after each session
調査の概要
状態
詳細な説明
Capacitive and resistive electric transfer (TECAR) therapy is a radiofrequency-based electrothermal modality designed to generate endogenous tissue heating. Preliminary evidence suggests that TECAR therapy may provide short-term improvements in pain and disability in individuals with low back pain. Some TECAR devices also incorporate a manufacturer-specific electrical stimulation function known as high-intensity electromyostimulation (Hi-EMS). However, the additional effects of combining Hi-EMS with TECAR therapy have not been established.
This randomized, assessor-blinded crossover trial will investigate whether adding Hi-EMS to TECAR therapy produces greater immediate improvements in pain and functional performance than TECAR therapy alone in individuals with chronic nonspecific low back pain. Each participant will receive both treatment conditions in a randomized order, allowing participants to serve as their own controls. The treatment sessions will be separated by a one-week washout period.
The study will evaluate immediate within-session responses and compare the magnitude of change between the two treatment conditions. The findings will help determine whether the concurrent use of Hi-EMS provides additional short-term benefits beyond those produced by TECAR therapy alone.
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：Richard Liebano, PhD
- 電話番号：860-768-8419
- メール：liebano@hartford.edu
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion criteria:
- 21 to 60 years old
- chronic nonspecific low back pain
- minimum pain intensity of 3 on a 0-10 scale
- be able to provide consent and comply with study procedures
Exclusion criteria:
- spinal fracture
- tumor
- radiculopathy
- neurological or vascular condition
- pregnancy
- cardiac pacemaker or other implanted device
- skin disorder or allergy
- altered sensation in the treatment area
- active or recent hemorrhage
- cognitive impairments
- liniments or heat rubs immediately before a study session
- treatment for low back within the previous 6 weeks
- currently receiving disability benefits because of low back pain
- current or pending litigation related to low back pain
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：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：TECAR Therapy Plus Hi-EMS
Participants will receive TECAR therapy with concurrent Hi-EMS.
The intervention will consist of 10 minutes of capacitive electrical transfer followed by 10 minutes of resistive electrical transfer, with Hi-EMS delivered only during the 10-minute resistive electrical transfer phase.
|
TECAR therapy will be delivered using the BACK4 system (Winback Europa SAS, Biarritz, France).
The intervention will consist of 10 minutes of capacitive electrical transfer (CET) followed by 10 minutes of resistive electrical transfer (RET).
A conductive cream will be applied to the treatment area, and a return plate will be positioned over the abdomen.
The Hi-EMS Focal mode will be activated only during the 10-minute RET phase and adjusted to produce a strong but comfortable stimulation without pain or excessive discomfort.
|
|
アクティブコンパレータ：TECAR Therapy Alone
Participants will receive TECAR therapy without Hi-EMS.
The intervention will consist of 10 minutes of capacitive electrical transfer followed by 10 minutes of resistive electrical transfer.
|
TECAR therapy will be delivered using the BACK4 system (Winback Europa SAS, Biarritz, France).
The intervention will consist of 10 minutes of capacitive electrical transfer (CET) followed by followed by 10 minutes of resistive electrical transfer (RET).
A conductive cream will be applied to the treatment area, and a return plate will be positioned over the abdomen.
Hi-EMS will not be activated during this condition.
|
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 at rest
時間枠：Immediately before and immediately after each treatment session
|
Low back pain intensity at rest will be assessed using an 11-point Numerical Pain Rating Scale (NPRS), ranging from 0 ("no pain") to 10 ("worst pain imaginable").
Participants will rate their current low back pain while at rest before performing the functional test.
Higher scores indicate greater pain intensity.
|
Immediately before and immediately after each treatment session
|
|
Movement-Evoked Pain Intensity
時間枠：Immediately before and immediately after each treatment session.
|
Movement-evoked low back pain intensity will be assessed immediately after the Five-Times-Sit-to-Stand Test using an 11-point Numerical Pain Rating Scale (NPRS), ranging from 0 ("no pain") to 10 ("worst pain imaginable").
Participants will rate the greatest low back pain experienced while performing the test.
Higher scores indicate greater pain intensity.
|
Immediately before and immediately after each treatment session.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pressure pain threshold
時間枠：Immediately before and immediately after each treatment session.
|
A computerized digital pressure algometer (AlgoMed, Medoc Ltd.) with a 1-cm² probe will assess lumbar pressure pain threshold (PPT).
Pressure will be applied at 40 kPa/s, and participants will press a response button when the sensation first becomes painful.
PPT will be measured three times bilaterally at sites 5 cm lateral to the L3 and L5 spinous processes, with 30-second intervals.
The measurements will be averaged to obtain a single lumbar PPT value at each assessment.
|
Immediately before and immediately after each treatment session.
|
|
Five-Times-Sit-to-Stand Test
時間枠：Immediately before and immediately after each treatment session.
|
Functional performance will be assessed using the Five-Times-Sit-to-Stand Test.
Participants will be instructed to complete five consecutive sit-to-stand repetitions as quickly and safely as possible.
The time required to complete five repetitions will be measured using a stopwatch.
The test will be performed twice, and the mean completion time of the two trials will be used for analysis.
|
Immediately before and immediately after each treatment session.
|
協力者と研究者
スポンサー
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
その他の研究ID番号
- Tecar and Back Pain
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?
IPD プランの説明
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
米国で製造され、米国から輸出された製品。
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