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

NCT02081456 | Completed Results DMC

• 1 other identifier: 20-242
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Radiculopathy

Outcome Measures

Primary Outcomes (2)

• Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion

  up to 2-4 day follow up

• Numeric Pain Rating Scale

  Measures perceived level of pain on a scale from 0 to 10, where 0 indicates 'no pain' and 10 indicates 'worst imaginable pain'. Therefore, lower scores are better. Outcome results are given and mean changes from pre to post interventions, therefore, a negative value indicates improvement.

  up to 2-4 day follow up

Secondary Outcomes (2)

• Neck Disability Index

  2-4 day follow up

• Patient Specific Functional Scale

  at 2-4 day follow up

Study Arms (2)

Therapeutic Ultrasound

ACTIVE COMPARATOR

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

Device: Therapeutic Ultrasound

Soft Tissue Mobilization

EXPERIMENTAL

Passive soft tissue mobilization to the neck and upper extremity

Other: Soft Tissue Mobilization

Interventions

Soft Tissue Mobilization 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.

Soft Tissue Mobilization

Therapeutic Ultrasound 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.

Therapeutic Ultrasound

Eligibility Criteria

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

You may qualify if:

• 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.)
• Positive response to upper limb neural provocation testing (ULNT 1) (see description below for details)
• Tenderness to palpation over the cervical nerve trunks, brachial plexus, or along the median nerve.
• 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.

You may not qualify if:

• Red flags noted in the medical screening questionnaire such as tumor, fracture, history of metabolic disease, prolonged history of corticosteroid use.
• 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.
• Cervical spine surgery within the last 3 months.
• Litigation associated with their neck and/or upper limb pain.
• Insufficient English language skills to complete the questionnaires and follow-up instructions.
• Inability to complete the treatment and follow-up schedule.
• Current pregnancy.

Sponsors & Collaborators

• Emilio J Puentedura, PT, DPT, PhD: lead

MeSH Terms

Conditions

Radiculopathy

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Results Point of Contact

• Title: Dr. Michael Costello, PT, DSc, OCS, MTC
• Organization: Cayuga Medical Center

mcostellopt@gmail.com

607-252-3500

Study Officials

• Michael Costello, PT, DSc

  Rocky Mountain University Health Sciences

  PRINCIPAL INVESTIGATOR

• Emilio j Puentedura, PT, DPT, PhD

  UNLV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 7, 2014
• Study Start: November 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 23, 2018
• Results First Posted: October 23, 2018

Record last verified: 2018-10