Hand and Upper Extremity IllnessNCT02493127
The Effect of Priming of Questionnaire Content on Grip Strength in Patients With Hand and Upper Extremity Illness
A study testing Standard PCS, Grip Strength and Positively Adjusted PCS in people with Hand and Upper Extremity Illness, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Objectives: To determine the association between priming and measurements of hand function such as grip strength Primary null hypothesis: There is no difference in grip strength (best of three attempts) as a percent of the opposite hand between patients that complete the standard Pain Catastrophizing Scale (PCS)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand and Upper Extremity Illness
- What is being tested?
- Standard PCS, Grip Strength and Positively Adjusted PCS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All English-speaking adult patients visiting the Orthopaedic Hand and Upper Extremity Service
Who cannot join
- Unable to complete enrollment forms due to mental status or language problem
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Objectives:
To determine the association between priming and measurements of hand function such as grip strength
Read more
Primary null hypothesis:
There is no difference in grip strength (best of three attempts) as a percent of the opposite hand between patients that complete the standard Pain Catastrophizing Scale (PCS) compared to patients that complete the positively adjusted PCS.
Secondary null hypotheses:
There is no difference in grip strength (last of three attempts) as a percent of the opposite hand between patients that complete the standard PCS compared to patients that complete the positively adjusted PCS.
There is no difference in grip strength (best of three attempts) before and after completing the questionnaires between patients that complete the standard PCS compared to patients that complete the positively adjusted PCS.
Read the detailed description
Priming affects all aspects of human behavior. Prior research by the investigators' group determined that completing a positively phrased version of the pain catastrophizing scale (PCS) primed patients to report less disability on average than completing the standard PCS. The influence of priming can be better understood by determining if it also affects direct measurements of hand function such as grip strength measures.
- Conditions
- Hand and Upper Extremity Illness
- Being tested
- Standard PCS, Grip Strength, Positively Adjusted PCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PCSOther
Subject completes the standard version of the PCS Questionnaire
Grip StrengthOther
Research Assistant takes Grip Strength Measurements
Positively Adjusted PCSOther
Subject completes the positively-adjusted version of the PCS Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Standard PCS | Experimental | Grip strength measurements and completes standard PCS Receives: Other: Standard PCS; Other: Grip Strength |
| Positive PCS | Experimental | Grip strength measurements and completes positively adjusted PCS Receives: Other: Grip Strength; Other: Positively Adjusted PCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Catastrophizing Scale (PCS)
The pain catastrophizing scale is a 13-item scale to measure catastrophic thinking. The scale is from 0-4 and scores range from 0-52, a lower score indicates less catastrophic thinking about pain.
Measured: enrollment
Positive Pain Catastrophizing Scale (PCS)
The positive pain catastrophizing scale (PCS) is a positively-phrased 13-item scale to measure catastrophic thinking. The scale is from 0-4 and scores range from 0-52, a higher score indicates less catastrophic thinking about pain.
Measured: enrollment
Difference in Grip Strength Measured With Dynamometer
Difference in Grip strength of the non-affected hand after completing intervention. Each participant completed the grip strength measurement 3 times on the non-affected hand at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.
Measured: Day 1
Difference in Grip Strength Measured With Dynamometer
Difference in Grip strength of the injured hand after completing intervention. Each participant completed the grip strength measurement 3 times on the injured hand at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.
Measured: Day 1
Difference in Grip Strength Measured With Dynamometer
Difference in Grip strength of both hands after completing intervention. Each participant completed the grip strength measurement 3 times with both hands at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hand and Upper Extremity IllnessStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David C. Ring, MD, Massachusetts General Hospital
- Investigators
- David C Ring, MD PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493127
- Sponsor's protocol ID
- 2015P000879
- Status last verified
- Mar 2017
- First submitted
- 15 Jun 2015
- Last updated
- 13 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Priming of Questionnaire Content on Grip Strength in Patients With Hand and Upper Extremity Illness
- ClinicalTrials.gov ID
- NCT02493127
- Acronym / sponsor ID
- 2015P000879
- Conditions
- Hand and Upper Extremity Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Posted 13 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
To determine the association between priming and measurements of hand function such as grip strength
Primary null hypothesis:
There is no difference in grip strength (best of three attempts) as a percent of the opposite hand between patients that complete the standard Pain Catastrophizing Scale (PCS) compared to patients that complete the positively adjusted PCS.
Secondary null hypotheses:
There is no difference in grip strength (last of three attempts) as a percent of the opposite hand between patients that complete the standard PCS compared to patients that complete the positively adjusted PCS.
There is no difference in grip strength (best of three attempts) before and after completing the questionnaires between patients that complete the standard PCS compared to patients that complete the positively adjusted PCS.
Detailed description
Priming affects all aspects of human behavior. Prior research by the investigators' group determined that completing a positively phrased version of the pain catastrophizing scale (PCS) primed patients to report less disability on average than completing the standard PCS. The influence of priming can be better understood by determining if it also affects direct measurements of hand function such as grip strength measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard PCS | Experimental | Other: Standard PCS, Other: Grip StrengthGrip strength measurements and completes standard PCS |
| Positive PCS | Experimental | Other: Grip Strength, Other: Positively Adjusted PCSGrip strength measurements and completes positively adjusted PCS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All English-speaking adult patients visiting the Orthopaedic Hand and Upper Extremity Service
Key exclusion criteria (1 listed)
- Unable to complete enrollment forms due to mental status or language problem
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 |
|---|---|---|
| Standard PCSSubject completes the standard version of the PCS Questionnaire | Other | Standard PCS |
| Grip StrengthResearch Assistant takes Grip Strength Measurements | Other | Positive PCS, Standard PCS |
| Positively Adjusted PCSSubject completes the positively-adjusted version of the PCS Questionnaire | Other | Positive PCS |
Primary outcome
Pain Catastrophizing Scale (PCS)
Time frame: enrollment
The pain catastrophizing scale is a 13-item scale to measure catastrophic thinking. The scale is from 0-4 and scores range from 0-52, a lower score indicates less catastrophic thinking about pain.
Positive Pain Catastrophizing Scale (PCS)
Time frame: enrollment
The positive pain catastrophizing scale (PCS) is a positively-phrased 13-item scale to measure catastrophic thinking. The scale is from 0-4 and scores range from 0-52, a higher score indicates less catastrophic thinking about pain.
Difference in Grip Strength Measured With Dynamometer
Time frame: Day 1
Difference in Grip strength of the non-affected hand after completing intervention. Each participant completed the grip strength measurement 3 times on the non-affected hand at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.
Difference in Grip Strength Measured With Dynamometer
Time frame: Day 1
Difference in Grip strength of the injured hand after completing intervention. Each participant completed the grip strength measurement 3 times on the injured hand at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.
Difference in Grip Strength Measured With Dynamometer
Time frame: Day 1
Difference in Grip strength of both hands after completing intervention. Each participant completed the grip strength measurement 3 times with both hands at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hand and Upper Extremity Illness
Recruiting
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Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Critical Illness
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.
David C Ring, MD PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard PCS, Grip Strength and Positively Adjusted PCS in people with Hand and Upper Extremity Illness, run by Massachusetts General Hospital 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 1 inclusion and 1 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 13 Apr 2017. 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?
Yes. Results are posted in the registry (first posted 13 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Catastrophizing Scale (PCS) (time frame: enrollment). The study lists 5 primary outcomes in all. 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 13 Apr 2017.