Chronic PainNCT05227963
Comparison Between Soft Tissue Mobilization and Strengthening Exercises in Management of Local Neck Syndrome
A study testing soft tissue mobilization and neck isometric strengthening exercises in people with Chronic Pain and Neck Pain, run by Health Education Research Foundation (HERF).
Trial summary
A single-blinded, parallel-group randomized controlled trial was conducted at the national institute of rehabilitation medicine, Pakistan, from April to July 2016, on 30 females who were recruited through non-probability convenient sampling technique and randomly allocated to the experimental and control group. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Neck Pain
- What is being tested?
- soft tissue mobilization and neck isometric strengthening exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 4 Apr 2016to 20 Aug 2021
- 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 30 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- :• Age above 30 and below 75 years
- Patients having local neck pain included
- Female included
- With chronic neck syndrome (> month)
Who cannot join
- Age below 30 and more than 75 years
- Patients having radiating pain excluded
- Male excluded.
- With acute neck syndrome (< 3 month)
About this study
A single-blinded, parallel-group randomized controlled trial was conducted at the national institute of rehabilitation medicine, Pakistan, from April to July 2016, on 30 females who were recruited through non-probability convenient sampling technique and randomly allocated to the experimental and control group.
Read the detailed description
The experimental group received STM and neck isometric strengthening exercises, whereas the control group received neck isometrics strengthening exercises only. Numeric Pain Rating Scale (NPRS) was used to assess the pain intensity, while Neck Disability Index (NDI) was used to assess the neck-related disability. The data was collected pre-, during, and post-intervention. Repeated measure analysis of variance (RM ANOVA) was used to analyze within the group changes, while independent t-test was used to analyze the differences between the groups. Data were analyzed by using SPSS version 21.
This study describes the comparative effectiveness of STM when used as adjunct to strengthening exercises and when strengthening exercises are used alone for the management of TNS. According to the results of this study, STM in combination with neck isometric strengthening exercises as well as exercises alone were effective for managing neck pain and functional disability when a comparison was made within the groups.
- Conditions
- Chronic Pain, Neck Pain
- Being tested
- soft tissue mobilization, neck isometric strengthening exercises
- Keywords
- Assessment, Neck pain, Pain measurements, Patient outcome assessment, Treatment outcome
- Medical subject headings
- Chronic Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft tissue mobilizationOther
In this group, each participants received 45-minutes long session that includes 25-minutes of soft tissue mobilization and 20-minutes of neck isometric strengthening exercises. In each session, patient was seated on chair and sustained pressure, direct oscillation, perpendicular mobilization, parallel mobilization, and friction massage was applied on the neck musculature for a minute followed by a release for 30 seconds. This protocol was repeated three times in each session. Each session was repeated four-times a week for two-weeks (a total eight sessions).
neck isometric strengthening exercisesOther
In this group, each participant received 20-minutes long session. Each session started in seated position and participants were asked to perform flexion, extension, side bending and rotation against resistance. During flexion movement, therapist placed hand on forehead and asked patient to move the neck forward, while in extension, therapist hand was placed at back of the head and patient had to move neck in backward direction. However, in side bending and rotation- therapist hand was placed at lateral side of the head and asked patient to side bend the neck and look at shoulder in the same direction respectively. Each session was repeated four-times a week for two-weeks (a total eight sessions).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group(Group A) | Experimental | Experimental Group received soft tissue mobilization with neck isometric strengthening exercises. Receives: Other: soft tissue mobilization; Other: neck isometric strengthening exercises |
| Control group (Group B) | Other | Control group received neck isometric strengthening exercises alone. Receives: Other: neck isometric strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical pain rating scale (NPRS)
NPRS was used to assess the pain intensity. The 11-point numeric scale ranging from 0-10; 0 means no pain while 10 means worst possible pain.
Measured: upto 2 weeks
Neck disability index (NDI)
NDI was used to assess the neck-related disability. Of the 50 score, 0-4 means no disability while 35-50 means severe disability.
Measured: upto 2 weeks.
Neck range of motion
Goniometer was used to measure the range of motion of neck.
Measured: upto 2 weeks .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start4 Apr 2016
- Primary completion10 May 2016
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The randomized control study was conducted in two groups,one was experimental group received soft tissue mobilization and other was control group received strengthening exercises with supportive treatment for both groups.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Education Research Foundation (HERF)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javairia Javaid, Health Education Research Foundation (HERF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227963
- Sponsor's protocol ID
- Ref.No.Research/21
- Status last verified
- Jan 2022
- First submitted
- 26 Oct 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Soft Tissue Mobilization and Strengthening Exercises in Management of Local Neck Syndrome
- ClinicalTrials.gov ID
- NCT05227963
- Acronym / sponsor ID
- Ref.No.Research/21
- Conditions
- Chronic Pain, Neck Pain
- Keywords
- Assessment, Neck pain, Pain measurements, Patient outcome assessment, Treatment outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Health Education Research Foundation (HERF)University, hospital or other
- Study start
- 4 Apr 2016 (actual)
- Primary completion
- 10 May 2016 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 8 Feb 2022 (actual)
- 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.
A single-blinded, parallel-group randomized controlled trial was conducted at the national institute of rehabilitation medicine, Pakistan, from April to July 2016, on 30 females who were recruited through non-probability convenient sampling technique and randomly allocated to the experimental and control group.
Detailed description
The experimental group received STM and neck isometric strengthening exercises, whereas the control group received neck isometrics strengthening exercises only. Numeric Pain Rating Scale (NPRS) was used to assess the pain intensity, while Neck Disability Index (NDI) was used to assess the neck-related disability. The data was collected pre-, during, and post-intervention. Repeated measure analysis of variance (RM ANOVA) was used to analyze within the group changes, while independent t-test was used to analyze the differences between the groups. Data were analyzed by using SPSS version 21.
This study describes the comparative effectiveness of STM when used as adjunct to strengthening exercises and when strengthening exercises are used alone for the management of TNS. According to the results of this study, STM in combination with neck isometric strengthening exercises as well as exercises alone were effective for managing neck pain and functional disability when a comparison was made within the groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The randomized control study was conducted in two groups,one was experimental group received soft tissue mobilization and other was control group received strengthening exercises with supportive treatment for both groups.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group(Group A) | Experimental | Other: soft tissue mobilization, Other: neck isometric strengthening exercisesExperimental Group received soft tissue mobilization with neck isometric strengthening exercises. |
| Control group (Group B) | Other | Other: neck isometric strengthening exercisesControl group received neck isometric strengthening exercises alone. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- :• Age above 30 and below 75 years
- Patients having local neck pain included
- Female included
- With chronic neck syndrome (> month)
Key exclusion criteria (4 listed)
- Age below 30 and more than 75 years
- Patients having radiating pain excluded
- Male excluded.
- With acute neck syndrome (< 3 month)
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 |
|---|---|---|
| soft tissue mobilizationIn this group, each participants received 45-minutes long session that includes 25-minutes of soft tissue mobilization and 20-minutes of neck isometric strengthening exercises. In each session, patient was seated on chair and sustained pressure, direct oscillation, perpendicular mobilization, parallel mobilization, and friction massage was applied on the neck musculature for a minute followed by a release for 30 seconds. This protocol was repeated three times in each session. Each session was repeated four-times a week for two-weeks (a total eight sessions). | Other | Experimental Group(Group A) |
| neck isometric strengthening exercisesIn this group, each participant received 20-minutes long session. Each session started in seated position and participants were asked to perform flexion, extension, side bending and rotation against resistance. During flexion movement, therapist placed hand on forehead and asked patient to move the neck forward, while in extension, therapist hand was placed at back of the head and patient had to move neck in backward direction. However, in side bending and rotation- therapist hand was placed at lateral side of the head and asked patient to side bend the neck and look at shoulder in the same direction respectively. Each session was repeated four-times a week for two-weeks (a total eight sessions). | Other | Control group (Group B), Experimental Group(Group A) |
Primary outcome
Numerical pain rating scale (NPRS)
Time frame: upto 2 weeks
NPRS was used to assess the pain intensity. The 11-point numeric scale ranging from 0-10; 0 means no pain while 10 means worst possible pain.
Neck disability index (NDI)
Time frame: upto 2 weeks.
NDI was used to assess the neck-related disability. Of the 50 score, 0-4 means no disability while 35-50 means severe disability.
Neck range of motion
Time frame: upto 2 weeks .
Goniometer was used to measure the range of motion of neck.
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 8 Feb 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing soft tissue mobilization and neck isometric strengthening exercises in people with Chronic Pain and Neck Pain, run by Health Education Research Foundation (HERF).
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 4 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 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Numerical pain rating scale (NPRS) (time frame: upto 2 weeks). The study lists 3 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 8 Feb 2022.