Physiotherapy Re-education of Pre-activation of the Transverse Abdominis in Patients With Chronic Low Back Pain

NCT03097497 | Completed DMC

• 1 other identifier: P14/089
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: The hypothesis of the study is that the physiotherapeutic re-education of the pre-activation of the transverse abdominal muscle decreases pain intensity in patients with chronic non-specific low-back pain by at least 30% and is more effective than conventional treatment. Aims: the principal aim is to determine the effectiveness of a physiotherapeutic re-education program based on the pre-activation of the transverse abdominal muscle on pain intensity in adult patients diagnosed with chronic non-specific low-back pain compared to conventional treatment in a primary care setting. The secondary aims of the study are to assess the effects of a physiotherapeutic re-education program based on the pre-activation of the transverse abdominal muscle on: (1) disability and limitations for the development of the activities of daily living associated with LBP, (2) transverse abdominal muscle muscle contraction, (3) to assess whether the resistance training parameters applied to older adults are valid for young adults and (4) to determine whether the training protocols used for the cervical spine could be extrapolated to the lumbar spine.

Conditions

Chronic Non-specific Low-Back Pain

Keywords

Chronic Non-specific Low-Back Pain; Chronic Low-Back Pain; Physiotherapy; Therapeutic Exercise; Primary Care; Transverse Abdominal Muscle

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity (from baseline)

  The Visual Analogue Scale (VAS) is an unidimensional scale developed to measure pain intensity. This scale consists on a line of 100-mm with a description on both extremes. "No pain" appears on the left side, representing a value of 0, and "worst pain ever" appears on the right side of the scale, representing a value of 100. A higher score on the scale will be indicative of greater pain intensity. Although no normative values are available in regard of the distribution of VAS scores, the following cut-off scores have been recommended: no pain (0-4mm), slight pain (5-44mm), moderate pain (45-74mm) and severe pain (75-100mm)

  4 weeks, 3 months, 6 months, 12 months

Secondary Outcomes (4)

• Oswestry Disability Index

  4 weeks, 3 months, 6 months, 12 months

• Roland-Morris Scale

  4 weeks, 3 months, 6 months, 12 months

• Transverse abdominal muscle contraction with Pressure Biofeedback Unit

  4 weeks, 3 months, 6 months, 12 months

• Surface Electromyography

  4 weeks, 3 months, 6 months, 12 months

Study Arms (2)

Physiotherapy re-education program

EXPERIMENTAL

Physiotherapy re-education program based on the pre-activation of the transverse abdominal muscle, performed with progressive difficulty and supervised at all times by an expert physiotherapist. The intervention will last 4 weeks, with two weekly sessions of 30-35 minutes each. Sessions will be held individually.

Other: Physiotherapy re-education program

Conventional treatment by GP

ACTIVE COMPARATOR

Will follow conventional treatment prescribed by the general practitioner in a primary care consultation. This conventional treatment is based on the clinical guidlines of the "Institut Català de la Salut" http://www.gencat.cat/ics/professionals/guies/docs/guia\_lumbalgies.pdf

Other: Conventional treatment by GP

Interventions

Physiotherapy re-education program OTHER

Physiotherapy Program based on the Re-education of Pre-activation of the Transverse Abdominal Muscle

Physiotherapy re-education program

Conventional treatment by GP OTHER

Patients will follow the general practitioner's advice including medication if needed

Conventional treatment by GP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being diagnosed of non-specific chronic low back pain of 3 or more months duration.
• Patients between 18-65 years old.
• To accept and sign the informed consent.

You may not qualify if:

• Patients with diagnosed of cognitive problems that prevent understanding the procedure or participation in the study.
• Any red flag condition:
• Age of pain onset \<20 or \>55
• Recent history of trauma
• Pain not associated with movement and not relieved by lying down
• Thoracic pain
• Past history of malignancy, recurrent of prolonged use of corticosteroids, immunosuppression/HIV
• Being systematically unwell
• Unexplained weight loss
• Neurological symptoms such as weakness of the limbs
• Structural deformity of the spine
• Women on pregnancy or postpartum less than three months.
• Difficulty understanding and/or speaking Spanish or Catalan

Sponsors & Collaborators

• Universitat de Lleida: lead

Study Sites (1)

Primary care setting

Lleida, 25198, Spain

Location

Related Publications (1)

• Rubi-Carnacea F, Masbernat-Almenara M, Climent-Sanz C, Soler-Gonzalez J, Garcia-Escudero M, Martinez-Navarro O, Valenzuela-Pascual F. Effectiveness of an exercise intervention based on preactivation of the abdominal transverse muscle in patients with chronic nonspecific low back pain in primary care: a randomized control trial. BMC Prim Care. 2023 Sep 6;24(1):180. doi: 10.1186/s12875-023-02140-3.

  PMID: 37674205 DERIVED

Study Officials

• Francesc J Rubí Carnacea, PhDc

  Universitat de Lleida

  PRINCIPAL INVESTIGATOR

• Jorge Soler González, GP

  Universitat de Lleida

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: March 18, 2017
• First Posted: March 31, 2017
• Study Start: April 30, 2017
• Primary Completion: August 30, 2017
• Study Completion: November 30, 2018
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

ES (1)