Efficacy of Ultrasound Versus Short Wave Diathermy in the Treatment of a Slipped Disc of the Lower Back

NCT03835182 | Completed

• 1 other identifier: KA13/236
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiculopathy; Low Back Pain, Mechanical; Herniated Disk Lumbar

Keywords

lumbar vertebrae; herniated disc; radiculopathy; low back pain; short wave therapy; diathermy; ultrasonic waves

Outcome Measures

Primary Outcomes (1)

• Change in level of pain

  visual analogue scale (VAS) score from 0 to 10cm for current pain. 0= no pain 10= the worst pain imaginable

  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 (2)

• Change in level of Disability

  Before treatment, 2 weeks after the commencement of treatment, 6 weeks after the commencement of treatment, 14 weeks after the commencement of treatment

• Change in health related quality of life

  Before treatment, 6 weeks after the commencement of treatment, 14 weeks after the commencement of treatment

Study Arms (3)

Ultrasound group

ACTIVE COMPARATOR

Thirty one patients receiving a total of ten sessions of physical therapy over a two week period. Each week the patients will receive five session of physical therapy on consecutive days. The ultrasound group will be treated with a hotpack (20minutes) transcutaneous electrical nerve stimulation (TENS) at a frequency of 100Hz intensity adjusted to the patient's tolerability (twenty minutes) and ultrasound 1MHz frequency (ten minutes) applied to the lower back, abdominal and lower back muscle strengthening exercises.

Device: Ultrasound group

Short wave diathermy group

ACTIVE COMPARATOR

The short wave diathermy group will consist of thirty one patients receiving a total of ten sessions of physical therapy over a two week period. Each week the patients will receive five session of physical therapy on consecutive days. The short wave diathermy group will be treated with a hotpack (20minutes), transcutaneous electrical nerve stimulation (TENS) at a frequency of 100Hz intensity adjusted to the patient's tolerability (twenty minutes) and short wave diathermy at a frequency of 27.12MHz (twenty minutes) applied to the lower back , abdominal and lower back muscle strengthening exercises.

Device: Short wave diathermy group

Control group

OTHER

The control group will consist of thirty one patients receiving a total of ten sessions of physical therapy over a two week period. Each week the patients will receive five session of physical therapy on consecutive days. The control group will be treated with a hotpack (20minutes) transcutaneous electrical nerve stimulation (TENS) at a frequency of 100Hz intensity adjusted to the patient's tolerability (twenty minutes) applied to the lower back , abdominal and lower back muscle strengthening exercises.

Other: Control group

Interventions

Ultrasound group DEVICE

Ultrasound 1 MHz, 1.5 W/cm2 for a total of 10 min applied to the lower back

Also known as: TENS, hotpack, exercise

Ultrasound group

Short wave diathermy group DEVICE

SWD frequency of 27.12MHz applied in continuous mode (thermic) applied to the lower back for twenty minutes

Also known as: Curapuls 419 SWD (Enraf-Nonius, Delft, The Netherlands), TENS, hotpack, exercise

Short wave diathermy group

Control group OTHER

superficial heat, analgesic physical modality and exercise only

Also known as: TENS, hotpack, exercise

Control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• )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

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University Faculty of Medicine, Ankara Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (9)

• Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman J, van Tulder MW. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis. BMJ. 2015 Feb 18;350:h444. doi: 10.1136/bmj.h444.

  PMID: 25694111 BACKGROUND

• Oral A, Ketenci A. Physical Medicine and Rehabilitation Approaches in the Management of Radicular Low Back Pain. A review of the Evidence and Current Recommendations. Turkish Journal of Physlcai and Rehabilitation Medicine 59:57-68, 2013

  BACKGROUND

• Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006.

  PMID: 17909209 BACKGROUND

• Jegede KA, Ndu A, Grauer JN. Contemporary management of symptomatic lumbar disc herniations. Orthop Clin North Am. 2010 Apr;41(2):217-24. doi: 10.1016/j.ocl.2010.01.003.

  PMID: 20399360 BACKGROUND

• Fiore P, Panza F, Cassatella G, Russo A, Frisardi V, Solfrizzi V, Ranieri M, Di Teo L, Santamato A. Short-term effects of high-intensity laser therapy versus ultrasound therapy in the treatment of low back pain: a randomized controlled trial. Eur J Phys Rehabil Med. 2011 Sep;47(3):367-73. Epub 2011 Jun 8.

  PMID: 21654616 BACKGROUND

• Chou R, Huffman LH; American Pain Society; American College of Physicians. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):492-504. doi: 10.7326/0003-4819-147-7-200710020-00007.

  PMID: 17909210 BACKGROUND

• Ahmed MS, Shakoor MA, Khan AA. Evaluation of the effects of shortwave diathermy in patients with chronic low back pain. Bangladesh Med Res Counc Bull. 2009 Apr;35(1):18-20. doi: 10.3329/bmrcb.v35i1.2320.

  PMID: 19637541 BACKGROUND

• Ozen S, Guzel S, Senlikci HB, Cosar SNS, Selcuk ES. Efficacy of ultrasound versus short wave diathermy in the treatment of chronic low back pain in patients with lumbar disk herniation: a prospective randomized control study. BMC Sports Sci Med Rehabil. 2023 Nov 20;15(1):157. doi: 10.1186/s13102-023-00769-2.

  PMID: 37986090 DERIVED

• 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.

  PMID: 32623724 DERIVED

MeSH Terms

Conditions

Radiculopathy; Low Back Pain; Intervertebral Disc Displacement; Fever

Interventions

Transcutaneous Electric Nerve Stimulation; Exercise Therapy; Control Groups; Exercise

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Body Temperature Changes

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Aftercare; Continuity of Patient Care; Patient Care; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sacide N Saracgil Cosar, MD

  Baskent University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator assessing the patient before and post treatment will be blind to the treatment received by the patient.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical and Rehabilitation Medicine Specialist

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 8, 2019
• Study Start: September 14, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)