Shoulder Weakness Following Neck Dissection Surgery Clinical Trial
Official title:
A Randomized Study to Assess the Efficacy of Early Physical Therapy Intervention on Upper Quarter Strength and Mobility, and Reported Upper Extremity Disability and Quality of Life Measures Following a Modified Unilateral Neck Dissection for Treatment of Head and Neck Cancer
| Verified date | May 2015 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
This study will determine whether patients who receive regular physical therapy immediately following a modified neck dissection surgery will report decreased shoulder disability, decreased pain, improved or maintained shoulder range of motion and strength, and improved quality of life than those who receive only home instruction.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - Adults age 18-85, able to give informed consent - Subject has provided written informed consent - Received Modified Unilateral Neck Dissection with sparing of the SAN - Not currently using transcutaneous electrical nerve stimulation (TENS) as a pain relieving modality - Not currently receiving acupuncture as a pain relieving modality - Able to participate with treatment group protocol including physical therapy appointment every other week Exclusion Criteria: - History of prior shoulder injury or surgery including rotator cuff repair or total shoulder arthroplasty. - History of CVA with hemi paresis - Bilateral neck dissection - Known severed SAN |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic | Phoenix | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Visual Analog Scale | Pain Scale | 12, 24, 36 weeks | No |
| Other | Strength, range of motion of the neck and shoulder | Measurements of shoulder range of motion and strength, cervical range of motion | 12, 24, 36 weeks | No |
| Primary | Disability of the Arm Shoulder and Hand | A standardized outcome tool which will be used to measure change in the level of disability related to involvement of the upper extremity at 12, 24, and 36 weeks compared to baseline. | 12, 24, 36 weeks | No |
| Secondary | SF-36 | General health survey. | 12, 24, 36 weeks | No |