Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain

Официальное название

Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation in Acute Low Back Pain

Обзор

The primary goal of this clinical trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial (RCT), considering recruitment, compliance with study protocols, and adverse events. The secondary goal is to evaluate the effectiveness of a video-based educational explanation of transcutaneous electrical nerve stimulation (TENS) in eliciting placebo-induced hypoalgesia and improving clinical outcomes in patients with acute low back pain. The main question it aims to answer is: Does the addition of a video-based educational explanation of TENS to standard physical therapy rehabilitation, consisting of TENS and exercises, increase the pressure pain threshold, reduce pain intensity, and improve functional mobility, patient satisfaction, and quality of life in patients with acute low back pain? Participants will be divided into two groups for comparison: the control group will receive standard physical therapy rehabilitation consisting of TENS and exercises, while the experimental group will receive the same program in addition to the video-based educational explanation of TENS.

Подробное описание

Pain modulation through expectation is a well-established phenomenon. Anticipating relief from a treatment can enhance the effects of both pharmacological and non-pharmacological analgesic interventions. The expectation of pain relief can reduce the perceived intensity of stimuli and is associated with changes in brain regions involved in pain processing, including the thalamus, prefrontal cortex, and somatosensory cortices. Previous research suggests that expectation can have a moderate to large effect on experimental and acute procedural pain.

Based on this, the investigators hypothesize that adding a video-based educational explanation of TENS to a standard physical therapy rehabilitation program will enhance patient expectations regarding the intervention. This may elicit placebo-induced hypoalgesia and improve clinical outcomes in patients with acute low back pain.

Вмешательства

• Устройство TENS
  12 sessions of TENS each lasting 45 minutes ,will be conducted over a 4-week intervention period .
• Поведенческое TENS educational explanation video
  The video provides standardized information on TENS, demonstrating its use, safety, and how it modulates pain through gate control theory
• Другое Exercise
  Participants will be provided with a home program consisting of exercises targeting trunk core activation, spinal mobility, and functional movement, as approved by the American Physical Therapy Association (APTA).

Первичные конечные точки

• Feasibility assessed using a structured feasibility questionnaire [Срок оценки: Baseline (Day 1) and 4 weeks post-treatment.]
• Success rate of obtaining consent from those eligible participants [Срок оценки: During the enrolment process]
• Retention rate of the participants [Срок оценки: Recorded at week 4 at the end of delivering the intervention.]
• Adherence of the participants [Срок оценки: Recorded at week 4 at the end of delivering the intervention.]

Вторичные конечные точки (5)

• Pressure Pain Threshold measured using a pressure algometer [Срок оценки: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.]
• Pain intensity measured using the Visual Analogue Scale (VAS) [Срок оценки: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.]
• Functional disability measured using the Oswestry Disability Index (ODI) [Срок оценки: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.]
• Participant satisfaction measured using the Visual Analogue Scale (VAS) [Срок оценки: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.]
• Health-related quality of life measured using the 36-Item Short Form Survey (SF-36) [Срок оценки: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.]

Критерии участия

Критерии включения

• acute low back pain without radicular pain to lower limbs
• minimal pain level of 4 on the 0-10 VAS
• 18-65 years of age
• TENS naïve or have not used TENS in the past 5 years.

Критерии исключения

• Radicular pain to lower limbs
• Serious spinal disorders, such as fractures, tumors, or inflammatory arthritis disease
• Nerve root disorders confirmed by neurological tests
• Neurological diseases
• Severe cardiorespiratory disease
• Pregnancy
• Skin infection or lesions or change in sensation at the TENS application site
• Cancer
• Cardiac pacemaker
• Allergy to electrodes
• use of opioids.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Cairo University Hospitals — Giza

Публикации

• Zaworski K, Baj-Korpak J, Tokarska-Rodak M, Plazuk E, Dyrda A, Bialosky J, Rossettini G. Can pre-treatment verbal suggestions influence the short-term effects of spinal manipulation in young adults with chronic non-specific low back pain? A randomized controlled trial. Musculoskelet Sci Pract. 2025 Nov;80:103431. doi: 10.1016/j.msksp.2025.103431. Epub 2025 Oct 10. PMID 41106172
• Meeuwis SH, Wasylewski MT, Bajcar EA, Bieniek H, Adamczyk WM, Honcharova S, Di Nardo M, Mazzoni G, Babel P. Learning pain from others: a systematic review and meta-analysis of studies on placebo hypoalgesia and nocebo hyperalgesia induced by observational learning. Pain. 2023 Nov 1;164(11):2383-2396. doi: 10.1097/j.pain.0000000000002943. Epub 2023 Jun 15. PMID 37326688
• Ruzic V, Ivanec D, Stanke KM. Effect of expectation on pain assessment of lower- and higher-intensity stimuli. Scand J Pain. 2017 Jan;14:9-14. doi: 10.1016/j.sjpain.2016.09.013. Epub 2016 Oct 27. PMID 28850443
• Peerdeman KJ, van Laarhoven AIM, Keij SM, Vase L, Rovers MM, Peters ML, Evers AWM. Relieving patients' pain with expectation interventions: a meta-analysis. Pain. 2016 Jun;157(6):1179-1191. doi: 10.1097/j.pain.0000000000000540. PMID 26945235

Идентификаторы

NCT: NCT07535047 · Placebo Induced Hypoalgesia

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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