Short-term Effectiveness of High- and Low-intensity Percutaneous Electrolysis in Patients With Low Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Pain changes in pain intensity before and after the intervention
Study Overview
Brief Summary
The goal of this observational study is to investigate the efficacy of percutaneous electrolysis compared with dry needling on pain sensations and multifidus muscle properties in subjects with low back pain. The main questions it aims to answer are:
The high-intensity and low-intensity percutaneous electrolysis may induce pressure pain threshold (PPT) changes in myofascial trigger points in the low back during the intervention compared with dry needling.
Percutaneous electrolysis interventions may reduce stiffness in the multifidus muscle during the intervention compared with dry needling.
Detailed Description
A parallel-group, controlled, triple-blinded, randomized pilot clinical trial comparing the effects of a single session of high-intensity percutaneous electrolysis (HIPE), low-intensity percutaneous electrolysis (LIPE), and dry needling (DN) applied to the multifidus muscle most active MTrP in subjects with low back pain. This clinical trial will follow the Consolidated Standards of Reporting Trials for pragmatic clinical trials.
This procedure consists of three trials, i.e., (1, HIPE) 660 uA x 30"; (2, LIPE) 220uA x 30"; and (3, DN) with 1 twitch response, and the needle inserted 30".
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 35 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •to report low back pain of at least six months duration,
- •aged 35 to 50 years,
- •at least one active trigger point is present in the multifidus muscle.
Exclusion Criteria
- •pharmacological (e.g., analgesics) or physiotherapy treatment before or during their participation in the study,
- •needle fear,
- •prior lower extremity or spine surgery, absence of pain, any musculoskeletal or neuropathic conditions (e.g., peripheral compressive neuropathy, radiculopathy, sarcopenia, fibromyalgia, muscle ruptures), traumatic injuries (e.g., fractures or fissures), or any medical condition or contraindication for needling treatment (e.g., anticoagulants).
Outcomes
Primary Outcomes
Pain changes in pain intensity before and after the intervention
Time Frame: Baseline, immediately after, and 24 after of intervention
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patient's current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area.
Secondary Outcomes
- Muscle stiffness(Baseline, immediately after, and 24 after of intervention)
- Pressure Pain Threshold(Baseline, immediately after, and 24 after of intervention)
Investigators
Sebastian Klich
Principal Investigator
Wroclaw University of Health and Sport Sciences