Clinical trial NCT03835182: Efficacy of Ultrasound Versus Short Wave Diathermy in the Treatment of a Slipped Disc of the Lower Back
Official title: Efficacy of Ultrasound Versus Short Wave Diathermy in the Treatment of Lumbar Disc Herniation: a Randomised Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiculopathy
Low Back Pain, Mechanical
Herniated Disk Lumbar
Keywords: lumbar vertebrae
herniated disc
radiculopathy
low back pain
short wave therapy
diathermy
ultrasonic waves
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 82
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Three groups of patients, each containing 31 patients, will be included in the study. Patients in each group will receive a total of ten sessions of physical therapy over a two week period. Each week the patients will receive five sessions of physical therapy on consecutive days. The first group will be treated with a hotpack (20minutes) transcutaneous electrical nerve stimulation applied to the lower back (frequency, ultrasound 1MHz frequency (ten minutes), abdominal and lower back muscle strengthening exercises. The second group will be treated with hotpack, TENS and exercises as previously described plus short wave diathermy at 27.12MHz frequency for ten minutes applied to the lower back. The third group will receive hotpack, TENS applied to the lower back and strengthening exercises as previously described.
Primary purpose: TREATMENT

Brief summary: Chronic low back pain is a common problem which results in reduced functionality, quality of life and general well being. Conservative treatment includes patient education, exercise, maintaining a healthy body mass index and appropriate modifications to activities of daily living. Physical modalities are used to support the mainstay of treatment and include superficial heat, transcutaneous electrical nerve stimulation (TENS), ultrasound, short wave diathermy , traction, and complimentary therapies.

In the clinical practice of the investigators, diathermy, in the form of ultrasound and short wave, is used to heat deeper tissues, increase tissue elasticity and metabolic rate and reduce pain and muscle spasm. The medical literature to date states that further studies are required to compare the efficacy of different diathermy modalities in the treatment of lower back pain.

The aim of this study was to compare the efficacy of ultrasound to that of short wave diathermy and a treatment program which does not include diathermy in the treatment of a slipped disc.

Detailed description: Chronic lumbar pain is a common problem which results in reduced functionality, quality of life and well being. Chronic low back pain also results in many missed days of work and so is an economic burden as well as a social one. Subacute and chronic conservative treatment of low back pain secondary to a herniated disc of the lower back includes education, lifestyle modifications, and maintenance of a normal body mass index. Physical therapy includes range of motion, strengthening and aerobic exercises alongside use of physical therapy modalities such as superficial heating, low frequency analgesic modalities such as TENS and deep heating modalities such as ultrasonic waves and short wave diathermy.

In Physical Medicine and Rehabilitation departments in Turkey, diathermy is commonly used as an adjunct to exercise in the inpatient treatment of disc herniation of the lumbar region. However, systematic reviews of the effects of diathermy in the form of ultrasound and short wave emphasise the necessity for further studies of their efficacy in the treatment of pain and impact on functionality and quality of life.

Therefore, in this study the investigators aim to compare the efficacy of ultrasound and short wave diathermy in treating pain, improving disability and quality of life in patients with chronic low back pain secondary to disc herniation of the lumbar vertebrae.

Eligibility criteria: Inclusion Criteria:

* 1)Age 20-60
* 2)Presenting to the Baskent University Faculty of Medicine Physical Medicine and Rehabilitation Department outpatient clinic
* 3) history of low back pain for greater than three months
* 4) Aetiology of back pain lumbar disc herniation based on history, examination and computed tomography/ magnetic resonance imaging (protruded, extruded disc)

Exclusion Criteria:

* 1)lower extremity neurological deficit, 2) infectious, inflammatory, metabolic, neoplastic, abdominal, pelvic aetiology of back pain. 3) a history of vertebral fracture, spinal surgery, spondylolisthesis 4) heat intolerance/medical contraindication to thermal treatment 5) presence of metal prosthesis

Primary outcomes:
measure: Change in level of pain
timeFrame: Before treatment, 2 weeks after the commencement of treatment, 6 weeks after the commencement of treatment, 14 weeks after the commencement of treatment
Secondary outcomes:
measure: Change in level of Disability
timeFrame: Before treatment, 2 weeks after the commencement of treatment, 6 weeks after the commencement of treatment, 14 weeks after the commencement of treatment
measure: Change in health related quality of life
timeFrame: Before treatment, 6 weeks after the commencement of treatment, 14 weeks after the commencement of treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University Faculty of Medicine, Ankara Hospital
Study officials:
affiliation: Baskent University Faculty of Medicine
name: Sacide N Saracgil Cosar, MD
role: STUDY_DIRECTOR
References:
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citation: Ebadi S, Henschke N, Forogh B, Nakhostin Ansari N, van Tulder MW, Babaei-Ghazani A, Fallah E. Therapeutic ultrasound for chronic low back pain. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD009169. doi: 10.1002/14651858.CD009169.pub3.