Shoulder Weakness Following Neck Dissection SurgeryNCT01729065
A Study to Assess the Efficacy of Early Physical Therapy Intervention Following a Modified Unilateral Neck Dissection for Treatment of Head and Neck Cancer
A study testing Physical therapy intervention in people with Shoulder Weakness Following Neck Dissection Surgery, run by Mayo Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Shoulder Weakness Following Neck Dissection Surgery
- What is being tested?
- Physical therapy intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Physical therapy intervention
- Keywords
- Spinal Accessory Nerve Palsy, Cranial Nerve XI, shoulder weakness, neck stiffness, head and neck cancer, neck dissection
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy interventionOther
Exercises addressing cervical range of motion, shoulder range of motion and strengthening and scapular stabilization.
| Study group | Role | What they receive |
|---|---|---|
| Home Program | No intervention | Participants perform home program only. |
| Physical Therapy Intervention | Experimental | Physical therapy intervention provided for first 12 weeks following surgery. Receives: Other: Physical therapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12, 24, 36 weeks
Secondary outcomes (1)
SF-36
General health survey.
Measured: 12, 24, 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startJan 2010
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Weakness Following Neck Dissection SurgeryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa M. Eden, Mayo Clinic
- Investigators
- Melissa M Eden, PT, DPT, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729065
- Sponsor's protocol ID
- 09-007403
- Status last verified
- May 2015
- First submitted
- 9 Nov 2012
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01729065
- Acronym / sponsor ID
- 09-007403
- Keywords
- Spinal Accessory Nerve Palsy, Cranial Nerve XI, shoulder weakness, neck stiffness, head and neck cancer, neck dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Program | No intervention | –Participants perform home program only. |
| Physical Therapy Intervention | Experimental | Other: Physical therapy interventionPhysical therapy intervention provided for first 12 weeks following surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapy interventionExercises addressing cervical range of motion, shoulder range of motion and strengthening and scapular stabilization. | Other | Physical Therapy Intervention |
Primary outcome
Disability of the Arm Shoulder and Hand
Time frame: 12, 24, 36 weeks
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.
1 secondary outcome
SF-36
Time frame: 12, 24, 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa M Eden, PT, DPT principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy intervention in people with Shoulder Weakness Following Neck Dissection Surgery, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability of the Arm Shoulder and Hand (time frame: 12, 24, 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015; AzTrials last refreshed its copy on 7 Nov 2026.