Clinical trial NCT06842381: Electrotherapy Combined With Neck Exercises for Non-Specific Neck Pain
Official title: Electrotherapy Combined With Neck Exercises for Non-Specific Neck Pain: Telerehabilitation Versus Face-to-Face Program: Study Protocol for a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
Collaborators: name: Andaluz Health Service
First posted: 2025-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: The objective of this study is to compare the effectiveness of telerehabilitation versus a face-to-face program in the therapeutic approach to non-specific neck pain through exercise and analgesic electrotherapy.

Methods: Randomized clinical trial on 100 participants with nonspecific neck pain who will be randomized into two groups to receive analgesic electrotherapy combined with a cervical exercise program through telemedicine or face to face. A total of 20 sessions will be applied over 8 weeks. Demographic and clinical data, disability, pain intensity, kinesiophobia, isometric spinal muscle strength, quality of life, and cervical mobility will be collected. Assessments will be performed at the beginning of the study (baseline), at 8 weeks (post-treatment) and 6 months after the end of the intervention (follow-up).

Detailed description: Introduction: Neck pain is a common problem in the working-age population, with a high recurrence rate and one of the highest health costs globally. Exercise is considered one of the keys in the management of this pathology, and electrotherapy is consolidated as a safe and proven analgesic measure. Telemedicine facilitates access to health care by eliminating geographical barriers and reducing costs, allowing consultations from any location and favoring the patient's work-life balance. The widespread availability of smartphones, tablets and computers makes telerehabilitation more accessible than ever.

Objectives: The objective of this study is to compare the effectiveness of telerehabilitation versus a face-to-face program in the therapeutic approach to non-specific neck pain through exercise and analgesic electrotherapy.

Methods: Randomized clinical trial with 100 participants with nonspecific neck pain who will be randomized into two groups to receive analgesic electrotherapy combined with a cervical exercise program through telemedicine or face to face. A total of 20 sessions will be applied over 8 weeks. Demographic and clinical data, disability, pain intensity, kinesiophobia, isometric spinal muscle strength, quality of life, and cervical mobility will be collected. Assessments will be performed at the beginning of the study (baseline), at 8 weeks (post-treatment) and 6 months after the end of the intervention (follow-up).

Eligibility criteria: Inclusion Criteria:

* Male and female patients between the ages of 30 and 65, with a medical diagnosis of cervical pain of non-specific origin,

  * Acceptance and signature of informed consent for voluntary participation in the research study.
  * Not receiving physical therapy.
* Chronic cervical pain lasting 3 months or more and not receiving any other type of physiotherapy treatment.

Exclusion Criteria:

* Patients undergoing rehabilitation treatment for pathologies of cervical origin.
* Patients have osteosynthesis material at the cervical level and/or cardiac complications, epilepsy or tumors.
* Patients who have undergone radiotherapy in the last 6 months.

Primary outcomes:
measure: Neck disability index
timeFrame: At baseline, 8 weeks and 6 months (follow up).
Secondary outcomes:
measure: Pain (Visual Analog Scale)
timeFrame: At baseline, 8 weeks and 6 months (follow up).
measure: McGill Pain Questionnaire (Disability)
timeFrame: At baseline, 8 weeks and 6 months (follow up).
measure: Quality of Life (SF-36 quality of life questionnaire)
timeFrame: At baseline, 8 weeks and 6 months (follow up).
measure: Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)
timeFrame: At baseline, 8 weeks and 6 months (follow up).
measure: Tampa scale for kinesiophobia
timeFrame: At baseline, 8 weeks and 6 months (follow up).
measure: Pain Catastrophizing Scale
timeFrame: At baseline, 8 weeks and 6 months (follow up).
measure: Cervical Range of Motion (Pro Motion Capture. Werium)
timeFrame: At baseline, 8 weeks and 6 months (follow up).
measure: Spinal Isometric Strength (SIS)
timeFrame: At baseline, 8 weeks and 6 months (follow up).
measure: Neck Flexor Muscle Endurance Test (NFME)
timeFrame: At baseline, 8 weeks and 6 months (follow up).
Other outcomes:
Locations:
Study officials:
References:
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