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Effects of an exercise program associated or not with an electrical current in patients with chronic low back pain

Effects of adding transcutaneous electrical nerve stimulation (TENS) during a walking program for individuals with chronic low back pain: blinded randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8tmrjvn
Enrollment
Unknown
Registered
2022-02-24
Start date
2022-03-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low back pain

Interventions

This is a double-blind randomized clinical trial, in which the researcher responsible for the evaluations will not know which group the participants will be allocated to, nor will the participants kno
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Sponsors

Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Lead Sponsor
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Collaborator

Eligibility

Age
30 Years to 59 Years

Inclusion criteria

Inclusion criteria: Individuals of both sexes, aged between 30 and 59 years, with a report of low back pain for more than 3 months, in addition to a minimum score of 3 points on the END and 37 points on the Tampa Scale of Kinesiophobia (ETC).

Exclusion criteria

Exclusion criteria: Regular practice in the last 6 months of any physical exercise program or sport; individuals with a history of fracture or surgical procedure in the lumbar spine; diagnosis of herniated disc with neurological repercussions; having undergone physical therapy treatment in the last month or previously with electrotherapeutic currents; use of analgesics, anti-inflammatory drugs or muscle relaxants in the last week; cancer diagnosis; pregnancy; presence of severe cardiovascular dysfunctions; medical diagnosis of fibromyalgia or other chronic pain in the lower limbs.

Design outcomes

Primary

MeasureTime frame
Pain intensity after 10 sessions. Assessed using the Numerical Pain Scale. This is to determine whether the treatment has a significant impact on reducing the participants' pain intensity after 10 sessions.

Secondary

MeasureTime frame
Pain intensity, 3 months after the end of training. Assessed using the Numerical Pain Scale. This is to determine whether the treatment has a significant impact on reducing the participants' pain intensity after 10 sessions and whether this reduction is maintained 3 months after the end of the treatment, indicating the effectiveness and sustainability of the results;Disability, after 10 sessions and 3 months after the end of training. Assessed using the Rolland Morris Disability Questionnaire. To assess whether the intervention has a significant impact on reducing participants' functional disability.;Perceived improvement after 10 sessions and 3 months after the end of training. Assessed using the Global Perceived Effect Scale. To assess whether there is a significant perception of improvement between the two time evaluations, indicating the impact and sustainability of the improvements perceived after the training.;Catastrophizing, after 10 sessions. Assessed by the Catastrophic Thoughts about Pain Scale. It is to determine whether there is a significant reduction in participants' catastrophic thoughts after the intervention, indicating an improvement in chronic pain management. ;Kinesiophobia, after 10 sessions. Assessed using the Tampa Kinesiophobia Scale. To assess whether the treatment made any difference to movement avoidance.;Skin impedance, after 10 sessions, will be assessed by bioimpedance. Evaluate whether there is a difference in the patient's skin impedance after treatment. ;Functional capacity after 10 sessions. Assessed by the 6-minute step test. To assess whether or not there was an improvement in functional capacity after the ten sessions.;Start Back Screening Tool, to assess whether the intervention has a significant impact on reducing low back pain and improving participants' functionality, as reflected by changes in SBST scores.

Countries

Brazil

Contacts

Public ContactRinaldo Roberto Guirro

Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

rguirro@fmrp.usp.br+55(16) 33154584 ou 4585

Outcome results

None listed

Source: REBEC (via WHO ICTRP)