Hand InjuryNCT00687427
Return to Work After Hand Injury: the Role of Medical, Demographic and Psycho-Social Factors
An observational study of Hand Injury, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to investigate the extent of return to work (RTW) after traumatic hand injury and to identify factors that are related to RTW. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hand Injury
- What is being tested?
- Questionnaires and motor/sensitivity testing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2008to Dec 2008
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Individuals will be recruited from those referred to occupational therapy department at Soroka Medical Center.
Who may be able to join
- The individual worked until he/she was injured
- Traumatic hand injury including: wrist fractures, fingers fractures, tendon injury, nerve injury, Crush injury, finger amputation
Who cannot join
- Non traumatic hand injury (such as CTS)
- Mallet finger
- Burns
- Injury in several organs
Trial locations and contacts
1 site in 1 country.
Israel1 site
Soroka University Medical Center, Occupational Therapy Department
Beersheba
Dorit Adin, BOT
About this study
Official title: Return to Work After Hand Injury: The Role of Medical, Demographic and Psychosocial Factors
The purpose of this study is to investigate the extent of return to work (RTW) after traumatic hand injury and to identify factors that are related to RTW.
Read the detailed description
RTW is one of the main rehabilitation outcomes after injury, the loss of the ability to work may have psychological as well as economic impact on the injured person. Time off work is also a burden to the economic system, associated with loss of work days, sick leave and national insurance payment. Hand injury can cause limitations in function, therefore influence the ability to work. Review of the literature reveals that time off work after hand injury ranges from a few days to a year and more. Factors associated with time off work include medical, socio-economic and psychosocial factors. Only a few studies have been conducted in Israel to investigate rate of RTW after hand injury and factors that affect RTW . The aim of this study is to explore the extent of RTW after traumatic hand injury and to examine the relationship between several factors - medical, demographic and psychosocial and RTW. This, in order to identify prognostic factors that can be treated during rehabilitation. There is no preliminary hypothesis made about the relationships between the factors and RTW. This study is also retrospective and prospective since it examine individuals under-going occupational therapy treatment and individuals who have been treated in the past.
- Conditions
- Hand Injury
- Being tested
- Questionnaires and motor/sensitivity testing
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and motor/sensitivity testingBehavioural
Group A:
- Full assessment (using the various measures described) will be carried out 0-3 weeks since referral.
- Treatment will focus on the patient's needs and in accordance with the physicians requests.
- Three months post initial treatment re-assessment will be conducted.
Questionnaires and motor/sensitivity testingBehavioural
Group B Researcher will contact by phone previous patients that were treated in the occupational therapy department in the past half year and a year, in order to get their permission to participate (retrospectively) in this research. After getting their consent, a questionnaire concerning their RTW will be posted to the subjects.
Questionnaires and motor/sensitivity testingBehavioural
Group C Researcher will contact by phone previous patients that were treated in the occupational therapy department in the past half year and a year, in order to get their permission to participate (retrospectively) in this research. After getting their consent, a questionnaire concerning their RTW will be posted to the subjects.
| Study group | Role | What they receive |
|---|---|---|
| A | Group A - 25 individuals or more, that start occupational therapy and agree to participate in the research. Receives: Behavioral: Questionnaires and motor/sensitivity testing | |
| B | Group B- 25 individuals or more, half a year after hand injury that were treated in occupational therapy at the same institute. Receives: Behavioral: Questionnaires and motor/sensitivity testing | |
| C | Group C - 25 individuals or more, a year after hand injury that were treated in occupational therapy at the same institute Receives: Behavioral: Questionnaires and motor/sensitivity testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
RTW vs no RTW
Measured: Group A: within 0-3 weeks from referral to occupational therapy treatment and again three months later or at the end of treatment .Group B: half a year after injury. Group C: one year after injury.
Secondary outcomes (4)
Medical, socio-demographic and work environment questionnaires
Measured: Group A: within 0-3 weeks from referral to occupational therapy treatment and again three months later or at the end of treatment .Group B: half a year after injury. Group C: one year after injury.
psychosocial questionnaires including: Post Traumatic Stress Disorder questionnaire, McGill Pain Questionnaire, pain belief and self-efficacy questionnaires.
Measured: Group A: within 0-3 weeks from referral to occupational therapy treatment and again three months later or at the end of treatment .Group B: half a year after injury. Group C: one year after injury.
Motor and sensitivity testing : hand grip and pinch strength measurements, Purdue Pegboard Test, Semmes-Weinstein Pressure Monofilaments, upper extremity rang of motion, Pain Visual Analogue Scale.
Measured: within 0-3 weeks from referral to occupational therapy treatment and again three months later or at the end of treatment .
Disabilities of Arm Shoulder and Hand questionnaire
Measured: Group A: within 0-3 weeks from referral to occupational therapy treatment and again three months later or at the end of treatment .Group B: half a year after injury. Group C: one year after injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startJun 2008
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Amiram Sagi, Professor, Principal investigator, Hand Surgery Unit, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687427
- Sponsor's protocol ID
- sor470708ctil
- Status last verified
- May 2008
- First submitted
- 27 May 2008
- Last updated
- 30 May 2008
- Results posted
- No
Publications
Bear - Lehman, J. (1983). Factors Affecting Return to Work After Hand Injury. American Journal of Occupational Therapy, 37 (3), 189 - 194. Chan, J., & Spencer, J. (2004). Adaptation to Hand Injury: An Evolving Experience. American Journal of Occupational Therapy, 58 (2), 128 - 139. Chan, J., & Spencer, J. (2005). Contrasting Perspectives on Pain following Hand Injury. Journal of Hand Therapy, Oct-Dec 18 (4),429 - 436. Chen, C.Y., Strecker Neufeld, P., Feely, C.H., & Skinner C.S. (1999). Factors Influencing Compliance With Home Exericise Programs Among Patients With Upper Extremity Impairment. American Journal of Occupational Therapy, 53 (2), 171 - 180. Deem, R. (1988). Work, Unemployment and Leisure. London: Routledge. DeGood, D.E., & Shutty, M.S. (1992). Assessment of Pain Beleifs, Coping, ans Self Efficancy. In D.C. Turk ,& R. Melzack (Eds), Hand Book of Pain Assessment, pp. 214 - 230. New York: The Guilford . Flood, A.B., Loernce, D.P., Ding, J., McPherson, K., & Black, N.A. (1993). The Role of Expectations in Patient's Reports of Post-Operative Outcomes and Improvement Following Therapy. Medical Care, 31 (11), 1043 - 1056. Franche R.L. & Krause N. (2002) Readiness for Return to Work Following Injury or Illness: Conceptualizing the Interpersonal Impact of Health Care, Workplace, and Insurance Factors. Journal of Occupational Rehabilitation,12 (4), 233 - 256. Gage, M. N., & Polatajko, H. (1994). Enhanching occupational performance through an understanding of percieved self-efficacy. American Journal of Occupational Therapy, 48, 452 - 461. Grunert, B.K., Matloub, H.S., Sanger, J.R., & Yousif, N.J. (1990). Treatment of Posttraumatic Stress disorder after work-related hand trauma. The Journal of Hand Surgery, 15A (3), 511 - 515. Jensen, P.J., Turner, J.A., Romano, J.M., & Lawler, B.K. (1994). Relationship of pain-specific beliefs to chronic pain adjustment. Pain , 57, 301 - 309. Johns, A.M. (1981). Time off work after hand injury. Injury ,Mar 12 (5), 417 - 424. Kasdan, M.L., & June, L.A. (1993). Returning to Work after Unilateral Hand Fracture. Journal of Occupational Medicine, 35(2), 132 - 136. Kelvin, P. & Jarret, J.E. (1985). Unemployment its social psychological effects. Cambridge University Press. Kilhofner, G. (2002). A Model of Human Occupation: Theory and Application (3 ed). Baltimore: Lippincott Williams & Wilkins. Krause, N., Frank, J.W., Dasinger, L.K., Sullivan. T.J., & Sinclair, S.J. (2001). Determinants of Duration of Disability and Return to Work after Work-Related Injury and Illness: Challenges for Future Research. American Journal of Industrial Medicine, 40, 464 - 484. Lai, C.H. (2004). Motivation in Hand-injured Patient with and without Work-related Injury. Journal of Hand Therapy, Jan-Mar 17 (1), 6 - 17. Melamed, S., Grosswasser, Z., & Stern, M.J. (1992). Acceptance of disability, work involvemnt and subjective rehabilitation status of traumatic brain injured (TBI) patients. Brain Injury, 6, 233 - 243. Mink Van Der Molen, A.B., Groothoff, J.W., Visser, J.P., Robinson, P.H., & Eisma, W.H. (1999). Time off Work due to Scaphoid Fracture and other Carpal Injuries in the Netherlands in the period 1990 to 1993. Journal of Hand Surgery (British and European Volume), 24b (2), 193-198. Pransky, G., Gatchel, R., Linton, S.J., & Loisel, P. (2005). Improving Return to Work Research. Journal of Occupational Rehabilitation, 15(4), 453 - 457. Rainwater, L. (1974). Work, Well-Being, and Family Life. In J. O'Toole (Ed), Work and the Quality of life, pp361-370. Cambridge Mass: Mit Press Rosberg, H.E., Steen-Carlsson, K., & Dahlin, L.B. (2005). Prospective study of patients with injuries to the hand and forearm: cost, function and genral health. Scandinavian journal of plastic and reconstructive surgery and hand surgey, 39 (6), 360-369. Rusch, M.D., Dzwierzynski, W.W., Sanger, J.R., Pruit, N.T., Siewert, A.D. (2003). Return to Work Outcomes after Work-Related Hand Trauma: The Role of Causal Attributions. The Journal of Hand Surgery, 28A, No. 4, 673 - 677. Schultz-Johnson, K. (1987). Assessment of Upper Extremity-injured persons' return to work potentail. Journal of Hand Surjery, 12A (5), 950 - 957. Skov, O., Jeune. B., Lauritsen J.M., & Barfred, T. (1999). Time off Work After Occupational Hand Injuries. Journal of Hand Surgery (British and European Volume), 24B (2): 187 - 189. Waylett-Rendall, J., & Niemeyer, L.O. (2004). Exploratory Analysis to Identify Factors Impacting Return-to-Work Outcomes in Cases of Cumulative Trauma Disorder. Journal of Hand Therapy, Jan-Mar, 17(1), 50 - 57.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Work After Hand Injury: The Role of Medical, Demographic and Psychosocial Factors
- ClinicalTrials.gov ID
- NCT00687427
- Acronym / sponsor ID
- sor470708ctil
- Conditions
- Hand Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jun 2008
- Study completion
- Dec 2008 (estimated)
- First posted
- 30 May 2008 (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.
The purpose of this study is to investigate the extent of return to work (RTW) after traumatic hand injury and to identify factors that are related to RTW.
Detailed description
RTW is one of the main rehabilitation outcomes after injury, the loss of the ability to work may have psychological as well as economic impact on the injured person. Time off work is also a burden to the economic system, associated with loss of work days, sick leave and national insurance payment. Hand injury can cause limitations in function, therefore influence the ability to work. Review of the literature reveals that time off work after hand injury ranges from a few days to a year and more. Factors associated with time off work include medical, socio-economic and psychosocial factors. Only a few studies have been conducted in Israel to investigate rate of RTW after hand injury and factors that affect RTW . The aim of this study is to explore the extent of RTW after traumatic hand injury and to examine the relationship between several factors - medical, demographic and psychosocial and RTW. This, in order to identify prognostic factors that can be treated during rehabilitation. There is no preliminary hypothesis made about the relationships between the factors and RTW. This study is also retrospective and prospective since it examine individuals under-going occupational therapy treatment and individuals who have been treated in the past.
Study design
- Observational model
- Cohort
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | Behavioral: Questionnaires and motor/sensitivity testingGroup A - 25 individuals or more, that start occupational therapy and agree to participate in the research. |
| B | – | Behavioral: Questionnaires and motor/sensitivity testingGroup B- 25 individuals or more, half a year after hand injury that were treated in occupational therapy at the same institute. |
| C | – | Behavioral: Questionnaires and motor/sensitivity testingGroup C - 25 individuals or more, a year after hand injury that were treated in occupational therapy at the same institute |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals will be recruited from those referred to occupational therapy department at Soroka Medical Center.
Key inclusion criteria (2 listed)
- The individual worked until he/she was injured
- Traumatic hand injury including: wrist fractures, fingers fractures, tendon injury, nerve injury, Crush injury, finger amputation
Key exclusion criteria (4 listed)
- Non traumatic hand injury (such as CTS)
- Mallet finger
- Burns
- Injury in several organs
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 |
|---|---|---|
| Questionnaires and motor/sensitivity testingGroup A: 1. Full assessment (using the various measures described) will be carried out 0-3 weeks since referral. 2. Treatment will focus on the patient's needs and in accordance with the physicians requests. 3. Three months post initial treatment re-assessment will be conducted. | Behavioural | A |
| Questionnaires and motor/sensitivity testingGroup B Researcher will contact by phone previous patients that were treated in the occupational therapy department in the past half year and a year, in order to get their permission to participate (retrospectively) in this research. After getting their consent, a questionnaire concerning their RTW will be posted to the subjects. | Behavioural | B |
| Questionnaires and motor/sensitivity testingGroup C Researcher will contact by phone previous patients that were treated in the occupational therapy department in the past half year and a year, in order to get their permission to participate (retrospectively) in this research. After getting their consent, a questionnaire concerning their RTW will be posted to the subjects. | Behavioural | C |
Primary outcome
RTW vs no RTW
Time frame: Group A: within 0-3 weeks from referral to occupational therapy treatment and again three months later or at the end of treatment .Group B: half a year after injury. Group C: one year after injury.
4 secondary outcomes
Medical, socio-demographic and work environment questionnaires
Time frame: Group A: within 0-3 weeks from referral to occupational therapy treatment and again three months later or at the end of treatment .Group B: half a year after injury. Group C: one year after injury.
psychosocial questionnaires including: Post Traumatic Stress Disorder questionnaire, McGill Pain Questionnaire, pain belief and self-efficacy questionnaires.
Time frame: Group A: within 0-3 weeks from referral to occupational therapy treatment and again three months later or at the end of treatment .Group B: half a year after injury. Group C: one year after injury.
Motor and sensitivity testing : hand grip and pinch strength measurements, Purdue Pegboard Test, Semmes-Weinstein Pressure Monofilaments, upper extremity rang of motion, Pain Visual Analogue Scale.
Time frame: within 0-3 weeks from referral to occupational therapy treatment and again three months later or at the end of treatment .
Disabilities of Arm Shoulder and Hand questionnaire
Time frame: Group A: within 0-3 weeks from referral to occupational therapy treatment and again three months later or at the end of treatment .Group B: half a year after injury. Group C: one year after injury.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2008.
- BackgroundBear - Lehman, J. (1983). Factors Affecting Return to Work After Hand Injury. American Journal of Occupational Therapy, 37 (3), 189 - 194. Chan, J., & Spencer, J. (2004). Adaptation to Hand Injury: An Evolving Experience. American Journal of Occupational Therapy, 58 (2), 128 - 139. Chan, J., & Spencer, J. (2005). Contrasting Perspectives on Pain following Hand Injury. Journal of Hand Therapy, Oct-Dec 18 (4),429 - 436. Chen, C.Y., Strecker Neufeld, P., Feely, C.H., & Skinner C.S. (1999). Factors Influencing Compliance With Home Exericise Programs Among Patients With Upper Extremity Impairment. American Journal of Occupational Therapy, 53 (2), 171 - 180. Deem, R. (1988). Work, Unemployment and Leisure. London: Routledge. DeGood, D.E., & Shutty, M.S. (1992). Assessment of Pain Beleifs, Coping, ans Self Efficancy. In D.C. Turk ,& R. Melzack (Eds), Hand Book of Pain Assessment, pp. 214 - 230. New York: The Guilford . Flood, A.B., Loernce, D.P., Ding, J., McPherson, K., & Black, N.A. (1993). The Role of Expectations in Patient's Reports of Post-Operative Outcomes and Improvement Following Therapy. Medical Care, 31 (11), 1043 - 1056. Franche R.L. & Krause N. (2002) Readiness for Return to Work Following Injury or Illness: Conceptualizing the Interpersonal Impact of Health Care, Workplace, and Insurance Factors. Journal of Occupational Rehabilitation,12 (4), 233 - 256. Gage, M. N., & Polatajko, H. (1994). Enhanching occupational performance through an understanding of percieved self-efficacy. American Journal of Occupational Therapy, 48, 452 - 461. Grunert, B.K., Matloub, H.S., Sanger, J.R., & Yousif, N.J. (1990). Treatment of Posttraumatic Stress disorder after work-related hand trauma. The Journal of Hand Surgery, 15A (3), 511 - 515. Jensen, P.J., Turner, J.A., Romano, J.M., & Lawler, B.K. (1994). Relationship of pain-specific beliefs to chronic pain adjustment. Pain , 57, 301 - 309. Johns, A.M. (1981). Time off work after hand injury. Injury ,Mar 12 (5), 417 - 424. Kasdan, M.L., & June, L.A. (1993). Returning to Work after Unilateral Hand Fracture. Journal of Occupational Medicine, 35(2), 132 - 136. Kelvin, P. & Jarret, J.E. (1985). Unemployment its social psychological effects. Cambridge University Press. Kilhofner, G. (2002). A Model of Human Occupation: Theory and Application (3 ed). Baltimore: Lippincott Williams & Wilkins. Krause, N., Frank, J.W., Dasinger, L.K., Sullivan. T.J., & Sinclair, S.J. (2001). Determinants of Duration of Disability and Return to Work after Work-Related Injury and Illness: Challenges for Future Research. American Journal of Industrial Medicine, 40, 464 - 484. Lai, C.H. (2004). Motivation in Hand-injured Patient with and without Work-related Injury. Journal of Hand Therapy, Jan-Mar 17 (1), 6 - 17. Melamed, S., Grosswasser, Z., & Stern, M.J. (1992). Acceptance of disability, work involvemnt and subjective rehabilitation status of traumatic brain injured (TBI) patients. Brain Injury, 6, 233 - 243. Mink Van Der Molen, A.B., Groothoff, J.W., Visser, J.P., Robinson, P.H., & Eisma, W.H. (1999). Time off Work due to Scaphoid Fracture and other Carpal Injuries in the Netherlands in the period 1990 to 1993. Journal of Hand Surgery (British and European Volume), 24b (2), 193-198. Pransky, G., Gatchel, R., Linton, S.J., & Loisel, P. (2005). Improving Return to Work Research. Journal of Occupational Rehabilitation, 15(4), 453 - 457. Rainwater, L. (1974). Work, Well-Being, and Family Life. In J. O'Toole (Ed), Work and the Quality of life, pp361-370. Cambridge Mass: Mit Press Rosberg, H.E., Steen-Carlsson, K., & Dahlin, L.B. (2005). Prospective study of patients with injuries to the hand and forearm: cost, function and genral health. Scandinavian journal of plastic and reconstructive surgery and hand surgey, 39 (6), 360-369. Rusch, M.D., Dzwierzynski, W.W., Sanger, J.R., Pruit, N.T., Siewert, A.D. (2003). Return to Work Outcomes after Work-Related Hand Trauma: The Role of Causal Attributions. The Journal of Hand Surgery, 28A, No. 4, 673 - 677. Schultz-Johnson, K. (1987). Assessment of Upper Extremity-injured persons' return to work potentail. Journal of Hand Surjery, 12A (5), 950 - 957. Skov, O., Jeune. B., Lauritsen J.M., & Barfred, T. (1999). Time off Work After Occupational Hand Injuries. Journal of Hand Surgery (British and European Volume), 24B (2): 187 - 189. Waylett-Rendall, J., & Niemeyer, L.O. (2004). Exploratory Analysis to Identify Factors Impacting Return-to-Work Outcomes in Cases of Cumulative Trauma Disorder. Journal of Hand Therapy, Jan-Mar, 17(1), 50 - 57.
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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.
Amiram Sagi, Professor principal investigator
Hand Surgery Unit, Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Injury, run by Soroka University Medical Center at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 30 May 2008. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asnat Bar Haim Erez, PhD (972 - 2 584 - 5309, aaerez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RTW vs no RTW (time frame: Group A: within 0-3 weeks from referral to occupational therapy treatment and again three months later or at the end of treatment .Group B: half a year after injury. Group C: one year after injury.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00687427, which also lists 1 linked publication.
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 30 May 2008.