Goal Setting Intervention for Chronic Knee Pain

(mGAME Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Paul Werth, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Non-English speaking, recent surgeries, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

To evaluate the effectiveness of the goal development intervention in guiding individual patients through the identification of high quality, specific, measurable, relevant and time-bound goal for treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Goal Setting Intervention for Chronic Knee Pain?

Research on similar treatments, like Goal Attainment Scaling (GAS) for chronic pain, shows that setting personal goals can help people manage their pain better. For example, in a study with older adults with arthritis, 76% of participants met their goals, and they found certain pain management methods more helpful after the intervention. ^{1 2 3 4 5}

Is goal setting intervention for chronic knee pain safe for humans?

Goal setting interventions, like Goal Attainment Scaling (GAS), have been used safely in various chronic pain conditions, including arthritis and low back pain, without reported safety concerns. ^{1 2 3 6 7}

How is the Goal Setting Intervention for Chronic Knee Pain treatment different from other treatments?

This treatment is unique because it uses Goal Attainment Scaling (GAS), which involves setting personalized goals for each patient and tracking their progress. Unlike standard treatments that may focus solely on physical symptoms, this approach considers the patient's personal aspirations and quality of life, making it more tailored and meaningful for the individual. ^{1 2 3 5 7}

Research Team

Paul Werth, PhD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

This trial is for adults over 21 who are new or existing patients scheduled to see an orthopaedic surgeon for knee issues. It's not open to those unable to consent, non-English speakers, or anyone less than a year out from prior spine, hip, or knee surgery.

Inclusion Criteria

I am 21 years old or older.

I am scheduled for a knee consult with an orthopaedic surgeon for a new issue.

Exclusion Criteria

I can consent and complete surveys without help.

I do not speak English.

I had knee surgery less than a year ago, spine surgery less than 6 months ago, or another knee/hip surgery less than 3 months ago.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the goal development intervention to identify high quality, specific, measurable, relevant, and time-bound goals for treatment

8 months

Follow-up

Participants are monitored for the effectiveness of the goal development intervention and shared decision making

4 weeks

Treatment Details

Interventions

• Goal Attainment (Behavioral Intervention)
• Goal Development (Behavioral Intervention)
• Goal Tracking (Behavioral Intervention)

Trial Overview The study tests a goal development intervention that helps patients set and track specific and measurable goals for their knee treatment. The effectiveness of this personalized approach will be evaluated.

Participant Groups

Group I: Goal Development and Tracking Intervention Active Control 2 Interventions

Group II: Goal Attainment Intervention Active Control 1 Intervention

Group III: Goal Development Intervention Active Control 1 Intervention

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Jonathan T. Huntington

Dartmouth-Hitchcock Medical Center

Chief Medical Officer since 2024

MD, PhD, MPH

Joanne M. Conroy

Dartmouth-Hitchcock Medical Center

Chief Executive Officer since 2017

MD from Medical University of South Carolina

Medacta USA

Industry Sponsor

Trials

17

Recruited

2,100+

Findings from Research

Goal attainment scaling (GAS) has been shown to be a feasible and patient-centered approach for individuals with low back pain (LBP), allowing patients to set personalized goals during rehabilitation.

GAS may be more sensitive to changes in patient outcomes compared to traditional fixed-item measures, suggesting it could enhance patient satisfaction and therapeutic effects, although it still requires further development and validation for effective use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goal attainment scaling for patients with low back pain in rehabilitation: A systematic review. Haladay, D., Swisher, L., Hardwick, D.[2022]

A new individualized assessment tool was developed to better capture meaningful changes in low back pain from the patient's perspective, involving 15 patients who identified 45 important goals related to their condition.

The majority of participants (69%) were able to define a 'minimal important change' for their goals, demonstrating that patients can effectively engage in setting targets for their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goal scaling for low back pain in primary care: development of a semi-structured interview incorporating minimal important change. Mullis, R., Hay, EM.[2021]

In a study involving 20 participants with chronic low back pain, patients identified 27 unique goals, primarily focused on physical activity, which were largely misaligned with standard clinical outcome measures used by physiotherapists.

The findings suggest that 76% of patient goals aligned with physical functioning outcomes recommended by the IMMPACT consortium, indicating that current clinical measures may not accurately reflect what is meaningful to patients, highlighting the need for a more collaborative approach in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient led goal setting in chronic low back pain-What goals are important to the patient and are they aligned to what we measure? Gardner, T., Refshauge, K., McAuley, J., et al.[2019]

Goal Attainment Scaling (GAS) is an effective tool for measuring client outcomes in rural and remote health services, allowing for individualized goal setting on a five-point scale.

GAS promotes collaboration between clinicians and clients, making it easier to summarize diverse service outcomes and ensuring that goals remain relevant and realistic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goal attainment scaling: an effective outcome measure for rural and remote health services. Cox, R., Amsters, D.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Goal attainment scaling for patients with low back pain in rehabilitation: A systematic review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Goal scaling for low back pain in primary care: development of a semi-structured interview incorporating minimal important change. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A goal attainment pain management program for older adults with arthritis. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Patient led goal setting in chronic low back pain-What goals are important to the patient and are they aligned to what we measure? [2019]

5. England pubmed.ncbi.nlm.nih.gov

Goal attainment scaling in evaluating a multidisciplinary pain management programme. [2017]

6. Australia pubmed.ncbi.nlm.nih.gov

Goal attainment scaling: an effective outcome measure for rural and remote health services. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The application of goal attainment scaling in chronic pain settings. [2019]