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Completed

NCT Number: NCT01496144

Manual Therapy on the Improvement of Functional Disability in Patients With Chronic Non Specific Low Back Pain

Background: Models have tried to explain the driving mechanisms behind chronic non specific low back pain (CNSLBP) in order to propose better appropriate conservative treatment. Altered responses at spinal and/or supraspinal level may affect the perception of pain and degree of disability of CNSLBP patients. Recent clinical recommendations still propose active exercises (AE) for CNSLBP. However, acceptance of exercises by patients may be limited by pain-related manifestations. Current evidences suggest manual therapy (MT) induces a short-term analgesic effect through neurophysiological mechanisms at peripheral, spinal and cortical levels. The aim of this study was first, to assess whether MT has an instant analgesic effect, and second, to compare the long-lasting effect on functional disability of MT followed by AE to sham therapy (ST) followed by AE. Methods: Forty-two CNSLBP patients without co-morbidities, randomly distributed into 2 treatment groups, received either spinal manipulation/mobilization (first intervention) plus AE (MT group; n = 22), or detuned ultrasound (first intervention) plus AE (ST group; n = 20). Eight therapeutic sessions were delivered over 4 to 8 weeks. Instant analgesic effect was obtained by measuring pain intensity (Visual Analogue Scale) before and immediately after the first intervention of each therapeutic session. Pain intensity, disability (Oswestry Disability Index) and fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire) were determined before treatment, after the 8th therapeutic session, and at 3- and 6-month follow-ups.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Département de l'appareil locomoteur (DAL), Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1005, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • suffering from non specific low back pain with or without symptoms in the lower extremity for a period between 12 and 26 weeks
  • can maintain the usual medication

Exclusion criteria

  • spinal fracture or surgery within the previous 6 months
  • pregnancy
  • neoplasia
  • spinal infection
  • spinal inflammatory arthritis
  • low back pain of visceral origin
  • severe sensitive and/or motor radicular deficit from nerve root origin of less than 6 months
  • score of 3/5 or more on the Waddell Score
  • on sick leaves from work for 6 months or more
  • psychiatric disorders
  • opioid medication
  • patient unable to collaborate (linguistic barrier; cognitive impairments)
  • radiologic abnormalities other than degenerative disease
  • clinical neurogenic claudication.

Treatment and study plan

Manual therapy and active exercises

Procedure

Spinal manipulation/mobilisation (5-10 minutes), consisting of passive accessory intervertebral movements, muscle-energy techniques and high velocity, low amplitude dynamic thrust.

Active exercises (20 minutes), consisting of mobility, stretching, strengthening and motor control exercises

Other names: Spinal mobilisation, Manipulation

Detuned ultrasound and active exercises

Procedure

Electrotherapy device inactivated and ineffective. Active exercises, consisting of mobility, stretching, strengthening and motor control exercises

Other names: Electrotherapy

Primary outcomes

  1. Visual Analogue Scale - VAS-pain

    Time frame: During treatment, over a period of 4 to 8 weeks

    self-report of clinical pain intensity, consisting of a 10 cm horizontal line scale on which is added the statements "no pain" on the left and "maximum intensity of pain" on the right

Secondary outcomes

  1. Fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire - FABQ)

    Time frame: Before randomization and untill 6 months after the end of treatment

    measures level of fear and avoidance beliefs about work and physical activity in patients with low back pain

Sponsors and collaborators

Lead sponsor

University of Applied Sciences of Western Switzerland

Other

Collaborators

  • Centre Hospitalier Universitaire Vaudois

Registry information

Official study title

Manual Therapy Followed by Specific Active Exercises Versus a Placebo Followed by Specific Active Exercises on the Improvement of Functional Disability in Patients With Chronic Non Specific Low Back Pain: a Randomized Controlled Trial

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
Dec 21, 2011
Registry last updated
Dec 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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