Efficacy of Shortwave Diathermy in Ulnar Nerve Entrapment on the Elbow

NCT04275505 | Completed

• 1 other identifier: naciyebilginbadur
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

It was aimed to see if there is any efficacy of short wave diathermy (SWD) in the treatment of ulnar nerve entrapment at the elbow (UNE). Ulnar nerve entrapment, following carpal tunnel syndrome (CTS), is the second most common upper extremity entrapment neuropathy. Ulnar nerve is compressed mostly in elbow region because of its anatomy. Conservative treatment choices are limited in ulnar nerve entrapment neuropathy and very few studies about UNE, are available in literature. The aim of this study was researching the efficacy of SWD which is a deep heating modality in treatment of UNE. SWD is used either continuous or pulsed mode. Continuous SWD is used for the purpose of heating. MATERIALS AND METHODS: 61 adult patients, who had been diagnosed with UNE clinically and electrophysiologically, were randomly assigned into two groups. Ten sessions of SWD was applied to the patients in the treatment group as 5 sessions per week for 2 weeks. Ten sessions of placebo SWD was applied to the patients in the control group as 5 times a week, for 2 weeks. All patients in both groups were given elbow splints and were informed to avoid symptom provocating activities. Patients were evaluated at baseline, at the end of the treatment and,1 and 3 months after the treatment. Besides physical examination, quick-DASH (disabilities of arm, shoulder, hand) and SF-36 were used to evaluate activities of daily life, dynamometer was used to evaluate grip force and VAS was used to evaluate pain severity.

Conditions

Ulnar Nerve Entrapment at Elbow

Keywords

shortwave diathermy, ulnar nerve entrapment at elbow

Outcome Measures

Primary Outcomes (2)

• pain in hand and elbow due to ulnar nerve entrapment

  the pain of the participants were measured with VAS (visiual analogy scale). the difference between pain in baseline and 3 months after treatment were compared in order to get the primary outcome measure

  3 months

• hand function in daily living activities

  the progress in function was measured with quick -DASH questionnaire. the baseline measure and 3 months after treatment measures were compared in order to get the primary outcome measure

  3 months

Study Arms (2)

treatment group

ACTIVE COMPARATOR

the participants were given 10 sessions of shortwave diathermy treatment and elbow splint and told to avoid symptom provoking activities

Other: shortwave diathermy treatment

control group

PLACEBO COMPARATOR

the participants were given 10 sessions of placebo shortwave diathermy treatment (the device was not turned on), elbow splint and told to avoid symtpom provoking activities

Other: placebo shortwave diathermy treatment

Interventions

shortwave diathermy treatment OTHER

shortwave diathermy is a deep heating physical therapy agent. It was found efficiaous in carpal tunnel syndrome which is an entrapment neuropathy like ulnar nerve entrapment so it was hypothesised that shortwave diathermy could be an effective treatment method in ulnar nerve entrapment.

treatment group

placebo shortwave diathermy treatment OTHER

shortwave device was not turned on while participants were asked to put their elbow into the device

control group

Eligibility Criteria

• Age: 16 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• UNE Diagnosis Criteria suggested by American Neurology Society (12);
• Ulnar nerve motor conduction velocity lower than 50 m/sec in elbow region
• Elbow region ulnar nerve motor conduction velocity 10 m/sec lower than forearm region
• More than 20% decrease in compound muscle action potential (CMAP) amplitude in above elbow stimulation compared to below elbow
• Evident difference in configuration of above elbow CMAP compared to below elbow
• If 2 of the criteria are positive it is a possible UNE diagnosis, and it is certain UNE diagnosis in case 3 criteria are positive.

You may not qualify if:

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• cervical radiculopathy
• brachial plexopathy
• ulnar nerve cut and trauma
• sensation deficit in application region
• diabetes mellitus
• polyneuropathy
• wound, burn, scar mark on forearm research region
• presence of implant, prothesis, pin in tissue
• not having well general health
• epilepsy
• presence of intrauterine device
• presence of hearing instrument
• presence of tumor, inflammatory states
• pregnancy or suspect of pregnancy

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Sureyyapasa Chest Diseases and Chest Surgery Hospital

Istanbul, Maltepe, 34754, Turkey (Türkiye)

Location

Related Publications (1)

• 1.Özçete Z.A, On A.Y. : Ulnar sinir tuzak nöropatileri. TürkFiz Tıp Rehab Derg. 56; 190-5, 2010 2. Robertson C, Saratsiotis J. A review of compressive ulnar neuropathy at the elbow. J Manipulative Physiol Ther 2005;28:345. 3. Piligian G, Herbert R, Hearns M, Dropkin J, Landsbergis P, Cherniack M. Evaluation and management of chronic workrelated musculoskeletal disorders of the distal upper extremity. Am J Ind Med 2000;37:75-93. 4. Sailer SM. The role of splinting and rehabilitation in the treatment of carpal and cubital tunnel syndromes. Hand Clin 1996;12:223-41. 5. Seror P. Nocturnal orthosis: a new treatment of compression of the ulnar nerve at the elbow. 30 cases. Rev Neurol (Paris). 1994 Oct;150(10):721-7. 6. Hong CZ, Long HA, Kanakamedala RV, Chang YM, Yates L. Splinting and local steroid injection for the treatment of ulnar neuropathy at the elbow: clinical and electrophysiological evaluation. Arch Phys Med Rehabil 1996;77:573-7. 7. Frasca G, Maggi L, Padua L, Ferrara PE, Granata G, Minciotti I, Marzetti E, Specchia A, Ronconi G, Rabini A, Bertolini C, Piazzini DB. Short-term effects of local microwave hyperthermia on pain and function in patients with mild to moderate carpal tunnel syndrome: a double blind randomized sham-controlled trial. Clin Rehabil. 2011 Dec;25(12):1109-18. Epub 2011 Sep 21. 8. Svernlöv B, Larsson M, Rehn K, Adolfsson L. Conservative treatment of the cubital tunnel syndrome. J Hand Surg Eur Vol 2009;34:201. 9. Zlowodzki M, Chan S, Bhandari M, et al. Anterior transposition compared with simple decompression for treatment of cubital tunnel syndrome. A meta-analysis of randomized, controlled trials. J Bone Joint Surg Am. 2007;89(12):2591-2598. 10. Gay JR, Love JG. Diagnosis and treatment of tardy paralysis of the ulnar nerve; based on a study of 100 cases. J Bone Joint Surg Am. 1947;29(4):1087-1097. 11. Jeffrey R. Basford, G. David Baxter. Therapeutic Physical Agents. Walter R. Frontera, Joel A. DeLisa( Eds.). Physical Medicine & Rehabilitation. 5. ed. Philadelphia: Lippincott Williams & Wilkins;2010 :1698-1700 12. Campbell WW. Guidelines in electrodiagnostic medicine. Practice parameter for electrodiagnostic studies in ulnar neuropathy at the elbow. Muscle Nerve Suppl 1999;8:S171-205. [Abstract] 13.Svernlöv B, Larsson M, Rehn K, Adolfsson L. Conservative treatment of the cubital tunnel syndrome. J Hand Surg Eur Vol 2009; 34:201. 14. Nakamichi K, Tachibana S, Ida M, Yamamoto S (2009) Patient education for the treatment of ulnar neuropathy at the elbow. Arch Phys Med Rehabil 90:1839-1845 15. Ozkan FU, Saygı EK, Senol S, Kapcı S, Aydeniz B, Aktas I, Gozke E. New treatment alternatives in the ulnar neuropathy at the elbow: ultrasound and low-level laser therapy. Acta Neurol Belg DOI 10.1007/s13760-014-0377-9 16. Incebiyik S, Boyaci A, Tutoglu A. Short-term effectiveness of short-wave diathermy treatment on pain, clinical symptoms, and hand function in patients with mild or moderate idiopathic carpal tunnel syndrome. J Back Musculoskelet Rehabil. 2014 Jul 24. [Epub ahead of print]

  RESULT

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Condition Hierarchy (Ancestors)

Ulnar Neuropathies; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Ulnar Nerve Compression Syndromes; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• naciye bilgin badur, doctor

  sureyyapasa chest diseases and chest surgery hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the participants did not know if they were in tratment group or control group. both of the group participants were asked to put their elbow into the shortwave diathermy device and they did not know if the device was turned on or off. the investigator (Naciye Bilgin Badur) did not know the participants group while performing physical examination before and after intervention in control visits. investigator and outcome assessor are the same person who is Naciye Blgin Badur
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: this study has 2 groups of participants. treatment group and control group. It is designed as randomized controlled double blind clinical trial.

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 19, 2020
• Study Start: February 1, 2013
• Primary Completion: March 31, 2013
• Study Completion: August 31, 2013
• Last Updated: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: as soon as the article is pressed as long as the article is in press
• Access Criteria: via article

Locations

TU (1)