Chronic Shoulder Pain Treatment: High Intensity Laser or Ultrasound

NCT02793401 | Completed Phase 4

• 1 other identifier: BursaYIERH
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aimed to evaluate the short-term efficacy of High Intensity LASER Therapy (HILT) and Ultrasound (US) treatment in chronic shoulder pain. It's a prospective, randomized, controlled, single blind study.141 patients were randomized into two groups, as HILT (n=71) and US (n=70) groups. HILT or US treatment was applied to the patients in addition to 14 sessions of Hotpack (Hp) + Balneotherapy + Exercise treatment. Pre-treatment (Pre-T), Post-treatment 1st day (Post-T1st day) and Post-T findings for the 30th day (Post-T 30th day) were recorded using the visual analog scale (VAS) and shoulder pain and disability index (SPADI) scoring.

Conditions

Shoulder Pain Chronic

Keywords

High Intensity Laser; Ultrasound; Chronic Shoulder Pain

Outcome Measures

Primary Outcomes (2)

• VAS

  Patients were evaluated using by visual analog scale(VAS) in pre-treatment (Pre-T), 15th day and 45th day. VAS is a frequently used test worldwide, for which reliability and safety studies have been performed.

  Change from Baseline in VAS scores at 15 days and 45 days

• SPADI

  Patients were evaluated using SPADI in pre-treatment (Pre-T), 15th day and 45th day. SPADI was developed to measure shoulder discomfort. Its evaluation includes two parts: pain and disability. Part 1 includes five questions in the pain subgroup and measures the pain experienced by the patient over the previous week using VAS (0 no pain, to 10,most severe pain). Part 2 is the disability subgroup and includes eight questions and measures the degree of difficulty (0 no difficulty, to 10, requires help) in the movements of the patient during the last week. SPADI includes 13 questions, and zero point refers to maximal well-being and 130 points refers to maximal sickness.The investigators evaluated each part of the SPADI (shoulder pain index (SPI), shoulder disability index (SDI) and total SPADI) separately.

  Change from Baseline in SPADI scores at 15 days and 45 days.

Study Arms (2)

HILT group

ACTIVE COMPARATOR

71 of the patients were in the HILT group

Device: Hıgh İntensity Laser (HILT); Device: Hotpack; Device: Transcutaneous electrical nerve stimulation; Other: Therapeutic exercises; Other: Balneotherapy

US Group

ACTIVE COMPARATOR

70 of the patients were in the US group.

Device: Ultrasound; Device: Hotpack; Device: Transcutaneous electrical nerve stimulation; Other: Therapeutic exercises; Other: Balneotherapy

Interventions

Hıgh İntensity Laser (HILT) DEVICE

HILT was performed using a BTL-6000 High Intensity Laser, 12 W(watt), 1064 nm device was a hot laser with Nd: YAG LASER source. In HILT group, the investigators applied the device on the shoulder area in two phases: phase I - analgesia, and phase II - biostimulation.

HILT group

Ultrasound DEVICE

BTL 4710 US device was applied at 3 MHz frequency, and 1.5watt/cm2 intensity over 25 cm2 surface area. Headpiece area of the device was 5 cm2, and the application was performed as the head of device was positioned at 90º (perpendicular) at full contact for 5 minutes by using gel, and performing continuous circular motions.

US Group

Hotpack DEVICE

All patients had the same physical therapy (PT) protocol including hot pack (HP) for 20 min/session,

HILT group; US Group

Transcutaneous electrical nerve stimulation DEVICE

All patients had the same physical therapy (PT) protocol includingTENS (Fizyotens 4000, Fizyomed Medical Devices Ltd,Turkey) (50-100 Hz) for 20 min/session,

Also known as: TENS

HILT group; US Group

Therapeutic exercises OTHER

All patients had the same physical therapy (PT) protocol including therapeutic exercises for shoulder muscles

HILT group; US Group

Balneotherapy OTHER

All patients had the same physical therapy (PT) protocol including balneotherapy in 38-40 °C thermomineralized water for 20 minutes.

HILT group; US Group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The presence of shoulder pain for more than 3 months patients.

You may not qualify if:

• Limitation in the shoulder movements of more than 20%,
• Receiving physical therapy and injection treatment to the same shoulder region in the previous year,
• Malignancy,
• The presence of radicular pain and cervical myofascial pain syndrome,
• A history of acute trauma,
• A prior history of fracture in the shoulder to be treated,
• A prior history of surgical intervention and implantation of a metal implant to the affected shoulder,
• Inflammatory rheumatoid disease.

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, 16320, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Ultrasonography; Transcutaneous Electric Nerve Stimulation; Exercise Therapy; Balneology

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Burcu Metin Ökmen, MD

  Bursa Yuksek Ihtisas Education and Research Hospital

  STUDY DIRECTOR

• Korgün Ökmen, MD

  Bursa Yuksek Ihtisas Education and Research Hospital

  PRINCIPAL INVESTIGATOR

• Kağan Özkuk, MD

  Abant İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital

  STUDY CHAIR

• Bilal Uysal, MD

  Abant İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital

  STUDY CHAIR

• Refia Sezer, MD

  Abant İzzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital

  STUDY CHAIR

• Engin Koyuncu, MD

  Ankara Physical Therapy and Rehabilitation Education and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: June 8, 2016
• Study Start: May 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 8, 2016

Record last verified: 2016-06

Locations

TU (1)