Chronic Pain Clinical Trial
Official title:
Effect of Regular Electrotherapy in Patients With Chronic Non-specific Neck Pain and Low-back Pain: a Randomized Controlled Double-blinded Pilot Trial
Verified date | July 2021 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized controlled double-blinded pilot trial was performed in the Medical University of Vienna, Department of Special Anesthesia and Pain Medicine between 2015 and 2018. Aim of the study was to assess the effect of regular electrotherapy applied on the spinal cord of patients with chronic non-specific neck pain and/or low-back pain. The hypothesis was that subjective feeling of pain, range of motion of the cervical and lumbar region, as well as the activity in daily living improved after weekly electrotherapy sessions for 30 min each.
Status | Completed |
Enrollment | 162 |
Est. completion date | October 16, 2018 |
Est. primary completion date | October 16, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Chronic neck pain and/or low back pain longer than 3 month - Minimum numeric pain rating scale equal or > 5 Exclusion Criteria: - Change in pain medication within 4 weeks prior or during the enrollment (except intake of rescue medication) - Additional pain therapies within 4 weeks prior or during the enrollment - Epilepsy - Pregnancy - Previous experience in TENS - Cardiac arrythmia/previous cardiac operation/implanted cardiac devices - Infection or malignancies affecting the spinal cord/previous spine operation - Severe radicular pain with acute paralysis in the extremities - Ongoing pension application |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Khadilkar A, Odebiyi DO, Brosseau L, Wells GA. Transcutaneous electrical nerve stimulation (TENS) versus placebo for chronic low-back pain. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD003008. doi: 10.1002/14651858.CD003008.pub3. Review. — View Citation
Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11. Review. — View Citation
Martimbianco ALC, Porfírio GJ, Pacheco RL, Torloni MR, Riera R. Transcutaneous electrical nerve stimulation (TENS) for chronic neck pain. Cochrane Database Syst Rev. 2019 Dec 12;12:CD011927. doi: 10.1002/14651858.CD011927.pub2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in numeric pain rating scale at 8 weeks compared to baseline | Change from baseline subjective pain sensation from 0 (no pain) to 10 (maximum pain) at 8 weeks | 8 weeks | |
Secondary | change in cervical range of motion at 8 weeks compared to baseline | Cervical range of motion measured in degree using CROM (cervical range of motion device; the higher the number, the better the mobility). | 8 weeks | |
Secondary | change in lumbar range of motion at 8 weeks compared to baseline | Lumbar range of motion measured in cm using the Modified Schober Method (measurement of the skin distance 10 cm above and 5 cm below the posterior superior iliac spine during anteflexion and retroflexion, respectively. The higher the value in anteflexion, the better the mobility; the smaller the measured skin distance in retroflexion, the better the mobility). | 8 weeks | |
Secondary | Change in activity in daily living influenced by neck pain at 8 weeks compared to baseline | Change in the activity in daily living after 8 weeks compared to baseline using a questionnaire called "Neck Disability Index" for cervicalgia: Minimum 0 points (no disability), maximum 50 Points (severe disability); score calculation: Points examined divided 50 times 100; the higher, the more disabled in daily living due to chronic neck pain. | 8 weeks | |
Secondary | Change in activity in daily living influenced by low back pain at 8 weeks compared to baseline | Change in the activity in daily living after 8 weeks compared to baseline using "Rolland Morris Disability Questionnaire" for low back pain: Minimum 0 points (no disability), Maximum 24 points. The higher the score, the more disabled due to low back pain. | 8 weeks |
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