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

Radiculopathy Clinical Trial

Official title:

Efficacy of Ultrasound Versus Short Wave Diathermy in the Treatment of Lumbar Disc Herniation: a Randomised Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03835182
• Other study ID #: KA13/236
• Status: Completed
• Phase: N/A
• Start date: September 14, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2023
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Herniated Disk Lumbar
• Hyperthermia
• Intervertebral Disc Displacement
• Low Back Pain
• Low Back Pain, Mechanical
• Radiculopathy

Intervention

Device:
• Ultrasound group
Ultrasound 1 MHz, 1.5 W/cm2 for a total of 10 min applied to the lower back
• Short wave diathermy group
SWD frequency of 27.12MHz applied in continuous mode (thermic) applied to the lower back for twenty minutes

Other:
• Control group
superficial heat, analgesic physical modality and exercise only

Locations

Country	Name	City	State
Turkey	Baskent University Faculty of Medicine, Ankara Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View Citation

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. Erratum In: Ann Intern Med. 2008 Feb 5;148(3):247-8. — View Citation

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. Erratum In: Ann Intern Med. 2008 Feb 5;148(3):247-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in level of Disability	Modified Oswestry Low Back Pain Disability Questionnaire. The Revised Oswestry Disability Index is a condition specific outcome measure for low back pain. The index consists of ten questions with six possible responses regarding the patient's back pain, (scored from 0-5), including the severity of pain and impact on activities of daily living. The minimum obtainable score is 0, the maximum obtainable score is 50. This score is then used to calculate the index percentage using the formula: [total score/(no. of questions answered x 5)]100. The higher the percentage, the greater the level of disability due to low back pain. The minimal detectable change (90% confidence interval)is 10%, change of less than 10% maybe attributed to measurement error.	Before treatment, 2 weeks after the commencement of treatment, 6 weeks after the commencement of treatment, 14 weeks after the commencement of treatment
Secondary	Change in health related quality of life	Short Form 36 (SF-36).The SF 36 is a generic health survey which assesses health concepts that are pertinent to functional status and well-being such as physical function, bodily pain, role limitations due to emotional and physical problems. The sub scale values are reported: physical functioning, bodily pain, vitality, general health, social functioning, emotional role, physical role, mental health. The lowest and highest possible raw score for the subscales are as follows: physical functioning 10-30, physical role 4- 8, bodily pain 2-12, general health 5-25, vitality 4-24, social functioning 2-10, emotional role 3-6, mental health 5-30. Higher values signify better well being in all subgroups. The raw score is then used to calculate the 'transformed scale: Transformed scale= [(actual raw score- lowest possible raw score)/possible raw score range]100	Before treatment, 6 weeks after the commencement of treatment, 14 weeks after the commencement of treatment