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The aim of this study is to evaluate the reduction of pain of two different treatments in patients with chronic low back pain. Patients were divided in two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles.
Background: Low back pain is one of the most common health problems and a leading cause of disability and absence from work. Between 70% and 80% of adults will experience an episode of low back pain and approximately 10.0% of them will become chronic. This has a direct impact on the lumbar stabilizing muscles, giving rise to both structural and functional changes. Among the different treatment options, it has been observed that both dry needling (DN) and percutaneous electrolysis (PE) are effective techniques in the management of musculoskeletal pain.
Aim: To evaluate whether the reduction of pain after the application of PE is superior to the one obtained with DN.
Methods: A single-blind randomized clinical trial will be conducted in patients with chronic low back pain. The subjects will be divided into two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles. The study variables will be: pain (VAS), disability index (Oswestry Scale), fear of movement (TSK-11SV) and quality of life (SF-12). The measurements will be assessed before, right after and 7 days after a single intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dry needling group | Active Comparator | The dry needling group will recibe a dry needling treatment with the Hong technique. |
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| Percutaneous electrolysis group | Experimental | The percutaneous electrolysis grupos will recibe a tratement of galvanic current at 1.5mA, with 3-5 impacts, for 3-5 seconds in the low back multifiud muscles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dry needling | Other | It consists in application of dry needling on active and/or latent TPs in low back multifidus muscles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity. Visual analogue scale. | A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain | At baseline, at 1 week after the last intervention, and 6-month follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| Disability. Oswestry Low Back Pain Disability Idex | It has 10 items associated to activities of daily living, each item has a punctuation from 0 to 5 points | At baseline, at 1 week after the last intervention, and 6-month follow-up period |
| Fear of Movement. Tampa Scale of kinesiophobia (TSK-11SV) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leire Lopez de Calle Sánchez, Grade | Contact | +34661620517 | leire.lopezc@edu.uah.es | |
| Samuel Fernandez Carnero, PhD | Contact | samuel.fernandezc@uah.es |
| Name | Affiliation | Role |
|---|---|---|
| Leire Lopez de Calle Sánchez, Grade | University of Alcala | Principal Investigator |
| Samuel Fernandez Carnero, PhD | University of Alcala | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campus Científico-Tecnológico UAH. Av. de León, 3A | Alcalá de Henares | Madrid | 28805 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28719509 | Background | Ng SK, Urquhart DM, Fitzgerald PB, Cicuttini FM, Hussain SM, Fitzgibbon BM. The Relationship Between Structural and Functional Brain Changes and Altered Emotion and Cognition in Chronic Low Back Pain Brain Changes: A Systematic Review of MRI and fMRI Studies. Clin J Pain. 2018 Mar;34(3):237-261. doi: 10.1097/AJP.0000000000000534. | |
| 17909209 |
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| ID | Term |
|---|---|
| D000079245 | Dry Needling |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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The subjects will be divided into two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles.
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40 sealed opaque envelopes will be prepared. 20 of the envelopes will contain ballots corresponding to the DN control group and 20 to the PE group. Only the examiner who will carry out the intervention will know the group of each participant. The main examiner will be the one who monitors the intervention without knowing which group each participant belongs to.
| Percutaneous electrolysis | Other | It consists in the application of intratissue percutaneous electrolysis with galvanic current as a cathodic flow electrode in the low back multifidus muscles. The intervention will be guided by ultrasound equipment medically certified. |
|
Is a 11-item questionnaire that measures the fear of movement and (re)injury. |
| At baseline, at 1 week after the last intervention, and 6-month follow-up period |
| Quality of life. SF-12 Health questionnaire. | SF-12 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life | At baseline, at 1 week after the last intervention, and 6-month follow-up period |
| Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006. |
| 37685576 | Background | Matheve T, Hodges P, Danneels L. The Role of Back Muscle Dysfunctions in Chronic Low Back Pain: State-of-the-Art and Clinical Implications. J Clin Med. 2023 Aug 24;12(17):5510. doi: 10.3390/jcm12175510. |
| 31151377 | Background | Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827. |
| 29952980 | Background | Hu HT, Gao H, Ma RJ, Zhao XF, Tian HF, Li L. Is dry needling effective for low back pain?: A systematic review and PRISMA-compliant meta-analysis. Medicine (Baltimore). 2018 Jun;97(26):e11225. doi: 10.1097/MD.0000000000011225. |
| 37458028 | Background | Fakontis C, Iakovidis P, Lytras D, Kasimis K, Koutras G, Ntinou SR, Kottaras A, Chatziprodromidou IP, Chatzikonstantinou P, Apostolou T. Efficacy of percutaneous needle electrolysis versus dry needling in musculoskeletal pain: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2023;36(5):1033-1046. doi: 10.3233/BMR-220408. |
| 34754834 | Background | Valera-Calero JA, Sanchez-Mayoral-Martin A, Varol U. Short-term effectiveness of high- and low-intensity percutaneous electrolysis in patients with patellofemoral pain syndrome: A pilot study. World J Orthop. 2021 Oct 18;12(10):781-790. doi: 10.5312/wjo.v12.i10.781. eCollection 2021 Oct 18. |