Soft Tissue Mobilization Versus Therapeutic Ultrasound for Subjects With Neck and Arm Pain

NCT ID: NCT02081456

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-06-30

Brief Summary

The purpose of this study is to investigate effects of soft tissue mobilization versus therapeutic ultrasound in subjects with neck and arm pain who demonstrate neural mechanical sensitivity.

Detailed Description

To investigate the immediate effects of soft tissue mobilization (STM) versus therapeutic ultrasound (US) in patients with neck and arm pain who demonstrate neural mechanical sensitivity. Twenty-three patients with neck and arm pain and a positive upper limb neurodynamic test (ULNT) were randomly assigned to receive STM or therapeutic US during a single session. Outcome measures were collected immediately before and after treatment, and at 2-4 day follow-up. Primary outcomes were the Global Rating of Change (GROC), range of motion (ROM) during the ULNT, and pain rating during the ULNT. Secondary measures included the Neck Disability Index (NDI), Patient-Specific Functional Scale (PSFS), Numeric Pain Rating Scale (NPRS), and active range of shoulder abduction motion combined with the wrist neutral or wrist extension.

Conditions

Cervical Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Therapeutic Ultrasound

Therapeutic ultrasound applied for a period of 5 minutes to the most painful region of the neck, then a second 5 minute dose at the most painful region of the upper extremity

Group Type: ACTIVE_COMPARATOR

Therapeutic Ultrasound

Intervention Type: DEVICE

Patients received therapeutic US applied for a period of 5 minutes to the most painful region of the neck, then a second 5-minute dose at the most painful region of the upper extremity. The US dose was 0.5 w/cm2, with sonation time 50% and frequency 1 MHz.40,52 The patient lay supine with the hand of the involved upper extremity placed on the abdomen and the elbow supported on a pillow. The two US doses and interaction time with the patient lasted a total of 15 minutes in an attempt to have equal patient/therapist contact between the two groups.

Soft Tissue Mobilization

Passive soft tissue mobilization to the neck and upper extremity

Group Type: EXPERIMENTAL

Soft Tissue Mobilization

Intervention Type: OTHER

Patients in the STM group received treatment in supine, with their head resting on one pillow and the involved UE positioned in abduction and external rotation to preload the neural structures of the upper limb. Manual pressure was applied to the soft tissues of the upper quadrant in a deep, stroking manner with the intention to improve the mobility of the soft tissues surrounding the pathway of the neural structures of the upper limb as well as any tender or tight tissues. The therapist spent approximately 7 minutes on the neck and scapular region, 4 minutes on the upper arm, and 4 minutes on the forearm and hand. The therapist was allowed to vary the time spent on each region according to his/her assessment of the patient's condition. The procedure lasted a total of 15 minutes.

Interventions

Soft Tissue Mobilization

Patients in the STM group received treatment in supine, with their head resting on one pillow and the involved UE positioned in abduction and external rotation to preload the neural structures of the upper limb. Manual pressure was applied to the soft tissues of the upper quadrant in a deep, stroking manner with the intention to improve the mobility of the soft tissues surrounding the pathway of the neural structures of the upper limb as well as any tender or tight tissues. The therapist spent approximately 7 minutes on the neck and scapular region, 4 minutes on the upper arm, and 4 minutes on the forearm and hand. The therapist was allowed to vary the time spent on each region according to his/her assessment of the patient's condition. The procedure lasted a total of 15 minutes.

Intervention Type: OTHER

Therapeutic Ultrasound

Patients received therapeutic US applied for a period of 5 minutes to the most painful region of the neck, then a second 5-minute dose at the most painful region of the upper extremity. The US dose was 0.5 w/cm2, with sonation time 50% and frequency 1 MHz.40,52 The patient lay supine with the hand of the involved upper extremity placed on the abdomen and the elbow supported on a pillow. The two US doses and interaction time with the patient lasted a total of 15 minutes in an attempt to have equal patient/therapist contact between the two groups.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Active movement dysfunction that could be related to mechanical sensitivity of the neural structures of the upper limb. (i.e. painful shoulder abduction with elbow extension that is limited more when the wrist is extended than when the wrist is in neutral.)

2. Positive response to upper limb neural provocation testing (ULNT 1) (see description below for details)

3. Tenderness to palpation over the cervical nerve trunks, brachial plexus, or along the median nerve.

4. Tender points or taut bands in the muscles of the upper quadrant including the scalenes, cervical paraspinals, trapezius, deltoid, pectoralis major or minor, rotator cuff, biceps, triceps, coracobrachialis, brachialis, radiobrachialis, pronator teres, supinator, forearm extensor, forearm flexor, pronator quadratus, and hand intrinsic muscles.

Exclusion Criteria

1. Red flags noted in the medical screening questionnaire such as tumor, fracture, history of metabolic disease, prolonged history of corticosteroid use.

2. Signs of central nervous system involvement such as hyper-reflexia (exaggerated response to deep tendon reflex testing), unsteadiness during gait, ataxia, disturbed vision, nystagmus, altered taste, positive Babinski's or Hoffman's reflexes.

3. Cervical spine surgery within the last 3 months.

4. Litigation associated with their neck and/or upper limb pain.

5. Insufficient English language skills to complete the questionnaires and follow-up instructions.

6. Inability to complete the treatment and follow-up schedule.

7. Current pregnancy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emilio J Puentedura, PT, DPT, PhD

OTHER

Sponsor Role: lead

Responsible Party

Emilio J Puentedura, PT, DPT, PhD

Co-Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Costello, PT, DSc

Role: PRINCIPAL_INVESTIGATOR

Rocky Mountain University Health Sciences

Emilio j Puentedura, PT, DPT, PhD

Role: STUDY_DIRECTOR

UNLV

Other Identifiers

20-242

Identifier Type: -

Identifier Source: org_study_id