An interventional study of Dry Needling and Heavy Slow Load Exercise in Bicep Tendinitis, Biceps; Tenosynovitis and Bicipital Tendinitis, Left Shoulder, sponsored by University of Colorado, Denver. Withdrawn at 2 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2021-06-30.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
The aim of the research is to determine if participants who receive physical therapy (physiotherapy) including soft tissue mobilization, dry needling, Heavy slow load (eccentric-concentric) exercise (with hand weights specific to the biceps muscle) and a comprehensive rotator cuff and scapular stabilization program achieve greater reductions in pain and disability in the short (3-4 weeks) and long term (6 months) compared to those who receive soft tissue mobilization and a comprehensive rotator cuff and scapular stabilization program. Both treatment approaches are within the standard of care for physical therapists, the aim being to determine the most effective treatment approach. Study participants will be recruited form clinicians and flyers within the university/hospital organization where the study is taking place. Participants will be asked to attend 6 physical therapy visits and complete 6 surveys about their pain and disability.
The overall purpose of the pilot study is to test the feasibility of methods and procedures for later use to conduct a large study to determine if patients who receive physical therapy including dry needling, heavy slow load exercise and a comprehensive rotator cuff and scapular stabilization program achieve greater reductions in pain and disability in the short (4 weeks) and long term (6 months) compared to those who receive soft tissue mobilization and a comprehensive rotator cuff and scapular stabilization program. A secondary purpose is to search for possible effects and associations between variables that may be worth following up in a subsequent, larger study.
Hypothesis: 1) Individuals with biceps tendinopathy who receive an intervention of soft tissue mobilization, dry needling (DN), heavy slow load exercise (HSLE) and a comprehensive rotator cuff and scapular stabilization program will demonstrate significant differences in disability and pain scores compared to the control group as measured by the:
Inclusion Criteria:
Clinical exam findings (must have positive findings for at least 1/2 of the following). Several tests have been described for isolating pathology of the LHBT, however literature has shown that none of these tests are specific enough in isolation to confirm the diagnosis9 and Speed's test and Yergason's test do not perform consistently and they do not generate a large change in post-test probability.59 Additionally, better diagnostic utility is accomplished when 2 highly sensitive tests and one highly specific test60 however, Speed's and Yergason's tests are both specific. Therefore, it was decided that 1/2 specific tests would still be potentially inclusive of the pathology since neither of the tests is specific enough to confirm diagnosis either combined or in isolation.9,61 A test cluster of Speed's test combined with biceps palpation was reported to have a sensitivity of 68% and a specificity of 49%.12
a. Speed's i. Speed's test (sensitivity 32%, specificity 75% for biceps pathology) was performed by having the clinician extend the elbow, supinate the arm and elevate the humerus with resistance to approximately 60 degrees; a positive test is pain in the bicipital groove region.62-64 b. Yergason's i. Yergason's test (sensitivity 43%, specificity 79% for biceps pathology) was performed by having the clinician flex the elbow to 90 degrees with a pronated forearm. The clinician would then have the patient resist supination with pressure at the patient's wrist. A positive test is pain in the area of the bicipital groove.65,66
Exclusion Criteria:
Participants will be randomized to 1 of 2 groups;
Patients in the intervention 1 (DN+HSLE) group will attend physical therapy one to two sessions per week for up to 4 weeks for a total of 6 sessions. Each treatment session will last for a total of 45 minutes. A standardized physical therapy program will be used and will include soft tissue mobilization to the shoulder and biceps tendon followed by DN, HSLE and a standardized exercise program. The DN will be performed with disposable stainless-steel needles (.3 X 40mm; Seirin; Weymouth, MA) inserted into the skin over the most painful and/or thickened areas of the tendon, confirmed with palpation. Prior to insertion of the needle the overlying skin will be cleaned with alcohol. The needle will be inserted into the tendon. The technique will be a fast-in and fast-out technique described by Chiavaras et al.26 for 20-30 repetitions per session in up to 3 areas. A HSLE program of the biceps muscle/tendon will follow each DN session and will be performed daily for the course of treatment and will be performed as described by McDevitt et al.30
Participants in the control group will attend physical therapy one to two sessions per week for up to 4 weeks for a total of 6 sessions. Each treatment session will last for a total of 45 minutes. A standardized physical therapy program will be used and will include soft tissue mobilization to the shoulder and biceps tendon and a standardized exercise program. Neither dry needling nor heavy slow load exercise will be integrated into the "control" plan of care. Participants will be instructed to do all activities that do not increase symptoms and avoid activities which aggravate symptoms as advice to maintain usual activity has been found to assist in recovery from shoulder pain. Both groups will be treated with a stretching and strengthening program. The rotator cuff and scapular stabilization strengthening and flexibility program
Individuals will complete the first 3 weeks of the study (either DN +HSLE or control) and will be asked to complete outcome measures (ASES, NPRS, DASH, SPADI, Medication usage, PSFS, GROC, PASS) at 3, 12 weeks, and 6 months, following the initiation of therapy for follow-up measurements.
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Exclusion Criteria:
Patients in the intervention 1 Dry Needling (DN)+heavy Slow Load Exercise (HSLE) group will attend physical therapy one to two sessions per week for up to 4 weeks for a total of 6 sessions. Each treatment session will last for a total of 45 minutes. A standardized physical therapy program will be used and will include soft tissue mobilization to the shoulder and biceps tendon followed by DN, HSLE and a standardized shoulder strengthening exercise program.
Other: Dry Needling · Other: Heavy Slow Load Exercise · Other: Rotator cuff and scapular stabilization exercise program · Other: Soft tissue mobilization
Patients in the control group will attend physical therapy one to two sessions per week for up to 4 weeks for a total of 6 sessions. Each treatment session will last for a total of 45 minutes. A standardized physical therapy program will be used and will include soft tissue mobilization to the shoulder and biceps tendon and a standardized exercise program. Dry needling nor heavy slow load exercise will not be integrated into the "control" plan of care.
Other: Rotator cuff and scapular stabilization exercise program · Other: Soft tissue mobilization
Dry needling directly to the long head of the biceps tendon. The DN will be performed with disposable stainless-steel needles (.3 X 40mm; Seirin; Weymouth, MA) inserted into the skin over the most painful and/or thickened areas of the tendon, confirmed with palpation. Prior to insertion of the needle the overlying skin will be cleaned with alcohol. The needle will be inserted into the tendon. The technique will be a fast-in and fast-out technique described by Chiavaras et al.26 for 20-30 repetitions per session in up to 3 areas. An eccentric-concentric exercise program of the biceps muscle/tendon will follow each DN session and will be performed daily for the course of treatment and will be performed as described by McDevitt et al.
Also known as: Manual Therapy
Eccentric exercise protocols have been found to be an effective treatment for tendinopathies of the upper and lower extremities and recent evidence supports heavy slow resistance training (including the addition of a concentric phase) as having better outcomes over eccentric exercise alone. Patients will use 1-5 pound weights to perform slow and controlled concentric and eccentric exercise to biceps muscle.
Also known as: Therapeutic Exercise
Both groups will be treated with a stretching and strengthening program. The rotator cuff and scapular stabilization strengthening and flexibility program used in this study has 3 phases and patients progress in phases based on their ability to perform a number of exercises using theraband or body weight resistance.
Also known as: Therapeutic Exercise
Both groups will receive soft tissue mobilization to the anterior shoulder.
Also known as: Manual Therapy
American Shoulder and Elbow Surgeons Scale (ASES) at Baseline
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability.
Time frame: Baseline
American Shoulder and Elbow Surgeons Scale (ASES) at 3 Weeks
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability.
Time frame: 3 weeks
American Shoulder and Elbow Surgeons Scale (ASES) at 12 Weeks
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability.
Time frame: 12 weeks
American Shoulder and Elbow Surgeons Scale (ASES) at 6 Months
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability.
Time frame: 6 months
Numeric Pain Rating Scale (NPRS) at Baseline
Pain: An 11-point NPRS will be used to measure pain intensity. Numeric pain scales have been shown to be reliable and valid.61-65 Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain.
Time frame: Baseline
Numeric Pain Rating Scale (NPRS) at 3 Weeks
Pain; An 11-point NPRS will be used to measure pain intensity. Numeric pain scales have been shown to be reliable and valid.61-65 Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain.
Time frame: 3 weeks
Numeric Pain Rating Scale (NPRS) at 12 Weeks
Pain; An 11-point NPRS will be used to measure pain intensity. Numeric pain scales have been shown to be reliable and valid.61-65 Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain.
Time frame: 12 weeks
Numeric Pain Rating Scale (NPRS) at 6 Months
Pain; An 11-point NPRS will be used to measure pain intensity. Numeric pain scales have been shown to be reliable and valid.61-65 Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain.
Time frame: 6 months
DASH score at Baseline
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH); The DASH is a 30 item, self-administered questionnaire that addresses symptoms and physical function in individuals with disorders of the upper limb.51 The DASH is scored from 0-100% (0% = no disability).
Time frame: Baseline
DASH score at 3 Weeks
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH);The DASH is a 30 item, self-administered questionnaire that addresses symptoms and physical function in individuals with disorders of the upper limb.51 The DASH is scored from 0-100% (0% = no disability).
Time frame: 3 weeks
DASH score at 12 Weeks
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH);The DASH is a 30 item, self-administered questionnaire that addresses symptoms and physical function in individuals with disorders of the upper limb.51 The DASH is scored from 0-100% (0% = no disability).
Time frame: 12 weeks
DASH score at 6 Months
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH);The DASH is a 30 item, self-administered questionnaire that addresses symptoms and physical function in individuals with disorders of the upper limb.51 The DASH is scored from 0-100% (0% = no disability).
Time frame: 6 months
Patient specific functional scale (PSFS) at Baseline
Patient assessment of function; The PSFS is a patient self-reported measurement tool used to assess functional change. Patients identify up to 5 activities at Baseline that they find difficult or impossible to perform due to their problem, and then rate the difficulty level of each activity from 0 (unable to perform) to 10 (able to perform activity at same level as before injury/problem). The sum of the 5 scores will be reported and assessed for change at subsequent timepoints
Time frame: Baseline
Patient specific functional scale (PSFS) at 3 Weeks
Patient assessment of function; The PSFS is a patient self-reported measurement tool used to assess functional change. Patients identify up to 5 activities at Baseline that they find difficult or impossible to perform due to their problem, and then rate the difficulty level of each activity from 0 (unable to perform) to 10 (able to perform activity at same level as before injury/problem). The sum of the 5 scores will be reported and assessed for change at subsequent timepoints
Time frame: 3 weeks
Patient specific functional scale (PSFS) at 12 Weeks
Patient assessment of function; The PSFS is a patient self-reported measurement tool used to assess functional change. Patients identify up to 5 activities at Baseline that they find difficult or impossible to perform due to their problem, and then rate the difficulty level of each activity from 0 (unable to perform) to 10 (able to perform activity at same level as before injury/problem). The sum of the 5 scores will be reported and assessed for change at subsequent timepoints
Time frame: 12 weeks
Patient specific functional scale (PSFS) at 6 Months
Patient assessment of function; The PSFS is a patient self-reported measurement tool used to assess functional change. Patients identify up to 5 activities at Baseline that they find difficult or impossible to perform due to their problem, and then rate the difficulty level of each activity from 0 (unable to perform) to 10 (able to perform activity at same level as before injury/problem). The sum of the 5 scores will be reported and assessed for change at subsequent timepoints
Time frame: 6 months
Global Rating of Change (GROC) at 3 Weeks
Patient perceived level of change; The fifteen-point global rating scale described by Jaeschke et al. will be used.53 The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively.
Time frame: 3 weeks
Global Rating of Change (GROC) at 12 Weeks
Patient perceived level of change; The fifteen-point global rating scale described by Jaeschke et al. will be used.53 The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively.
Time frame: 12 weeks
Global Rating of Change (GROC) at 6 Months
Patient perceived level of change; The fifteen-point global rating scale described by Jaeschke et al. will be used.53 The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively.
Time frame: 6 months
Medication Usage at Baseline
Use of medication; medication name, dose and frequency per day/week will be tracked
Time frame: baseline
Medication Usage at 3 Weeks
Use of medication; medication name, dose and frequency per day/week will be tracked
Time frame: 3 weeks
Medication Usage at 12 Weeks
Use of medication; medication name, dose and frequency per day/week will be tracked
Time frame: 12 weeks
Medication Usage at 6 Months
Use of medication; medication name, dose and frequency per day/week will be tracked
Time frame: 6 months
Should Pain and Disability Index
participant report of shoulder related pain and disability (how shoulder pain limits function)
Time frame: Baseline
Should Pain and Disability Index
participant report of shoulder related pain and disability (how shoulder pain limits function)
Time frame: 3 weeks
Should Pain and Disability Index
participant report of shoulder related pain and disability (how shoulder pain limits function)
Time frame: 12 weeks
Should Pain and Disability Index
participant report of shoulder related pain and disability (how shoulder pain limits function)
Time frame: 6 months
Plan to share: No — There is not a plan at this time
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