- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07926789
Neuromuscular Taping on Muscle Pain in Patients With Degenerative Osteoarticular Disease of the Spine
Randomized Clinical Trial to Evaluate the Efficacy of Neuromuscular Taping on Muscle Pain in Patients With Degenerative Osteoarticular Disease of the Spine
The goal of this clinical trial is to learn if neuromuscular taping (kinesio taping), added to a standard exercise program, reduces muscle pain in adults with chronic neck pain or chronic low back pain caused by degenerative disease of the spine (such as facet joint osteoarthritis, spondylosis, or degenerative disc disease). The main questions it aims to answer are:
Does neuromuscular taping, applied once a week for 3 weeks in addition to standard exercise therapy, reduce muscle pain more than placebo taping?
Researchers will compare neuromuscular taping applied with a muscle and fascial technique to placebo taping (the same tape placed on the same area without tension or therapeutic technique) to see if the active taping provides greater pain relief.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Noemí Casaponsa
- Phone Number: 43197 0034938960025
- Email: recerca@csapg.cat
Study Locations
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Barcelona, Spain
- Consorci Sanitari Alt Penedès Garraf
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Contact:
- Sandra Herrero
- Phone Number: 0034938960025
- Email: aherrerol@csapg.cat
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women aged 18 years or older
- Persistent pain (duration of more than 3 months) with a diagnosis of chronic -neck pain or chronic low back pain due to degenerative joint disease
- Stable pain treatment, with no changes expected during the following 3 weeks
- Willingness to participate and signed informed consent
Exclusion Criteria:
- Cervicobrachialgia (neck pain radiating to the arm)
- Lumbosciatica (low back pain radiating to the leg)
- Pregnancy in the second or third trimester
- Skin conditions that contraindicate the application of neuromuscular tape
- Allergy to adhesive materials
- Thrombosis or risk of thrombosis
- Severe trauma that has not been previously examined and diagnosed by a physician
- Participation in another clinical trial involving an experimental intervention during the period of this trial and/or with a visit schedule incompatible with this trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Participants will have neuromuscular tape applied to the neck or lower back after the first exercise session of each week, and remove it on the fourth day |
The muscle technique consists of applying the tape without stretching it. Either the muscle or the skin is placed under stretch, but the tape itself is applied with no tension along its entire length. The base anchor is applied with the body segment in a neutral position; the target muscle is then stretched and the tape is laid over it. Finally, the segment is returned to the neutral position and the end anchor is applied. This technique is used to inhibit muscle tone. Once the tape has been applied, patients will be instructed to remove it on the fourth day. They may carry on with their normal daily activities and may get the tape wet when washing or showering. If the tape causes significant discomfort, patients may remove it early and must record this in their pain diary. If the tape comes off before the fourth day, patients must also record this in the diary. |
|
Sham Comparator: Control
These patients will have the same tape placed on the same area without tension or therapeutic technique |
The same tape placed on the same area without tension or therapeutic technique |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: From enrollment to the end of treatment at 4 weeks
|
Pain intensity, measured using a Visual Analog Scale (VAS). Pain will be recorded before the first treatment session of each week. Since treatment consists of two physiotherapy sessions per week for four weeks, the VAS will be recorded at the start of sessions 1, 3, 5, and 8, the last of which corresponds to the final day of treatment. In addition, patients will complete a pain diary every day between treatment sessions. |
From enrollment to the end of treatment at 4 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSAPG-31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
IPD Sharing Time Frame
After publication of main results of the study
IPD Sharing Access Criteria
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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