Dry needling, neuromuscular taping, therapeutic exercise, or all three in sequence, for older women with chronic lower-limb pain: effects on quality of life

ISRCTN ISRCTN26590288
DOI https://doi.org/10.1186/ISRCTN26590288
Sponsor Faculty of Health Studies, University of Mostar
Funder Investigator initiated and funded
Submission date
02/11/2026
Registration date
03/11/2026
Last edited
02/11/2026
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Chronic pain in the hip, knee or ankle can limit daily activity and quality of life in older women. The study aimed to compare four physiotherapy programmes: dry needling, neuromuscular taping, a kinesitherapy programme, and the three given in that order. There was no untreated group. The main question was quality of life after 4 weeks. Pain, physical fitness, daily function and body measurements were also recorded.

Who can participate?
Women aged 60 years or older, retired and living in the community, who were members of the Centre for Healthy Ageing of the Municipality of Novo Sarajevo and had lower-limb pain for more than 3 months that affected daily activity.

What does the study involve?
Each woman was allocated to one of the four programmes. Each programme comprised six sessions over 4 weeks. Quality of life was assessed before the first session and after the last session. Pain, a senior fitness test, daily function, vital signs and body composition were measured at the same two times.

What are the possible benefits and risks of participating?
No benefit was promised. Needling can cause short-lived soreness, tape can irritate the skin, and exercise requires physical effort. Participation was voluntary, with written consent.

Where is the study run from?
The Centre for Healthy Ageing (Bosnia and Herzegovina)

When is the study starting and how long is it expected to run for?
January 2022 to February 2022

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Edin Krupalija, edin.krupalija@gmail.com

Contact information

Mr Edin Krupalija
Public, Scientific, Principal investigator

Zrinskog Frankopana 34
Mostar
88000
Bosnia and Herzegovina

ORCiD logoORCID ID 0000-0002-0806-432X
Phone +387 (0)63031330
Email edin.krupalija@gmail.com

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingOpen (masking not used)
ControlActive
AssignmentParallel
PurposeTreatment
Scientific titleEffects of dry needling, neuromuscular taping, a kinesitherapy programme, and their sequential combination on quality of life in community-dwelling older women with chronic lower-limb pain: a four-arm randomised comparison
Study objectives To compare dry needling, neuromuscular taping, a kinesitherapy programme, and their sequential combination on quality of life in older women with chronic lower-limb pain. There was no untreated or sham group.
Ethics approval(s)

Approved 31/12/2021, Ethics Committee of the Centre for Healthy Ageing, Municipality of Novo Sarajevo (Azize Šaćirbegović 96, Sarajevo, 71000, Bosnia and Herzegovina; +387 (0)61349554; edina@zdravostarenje.ba), ref: 43-P/21

Health condition(s) or problem(s) studiedChronic lower-limb pain in community-dwelling older women
InterventionAfter written consent, 44 women were assigned to four groups of 11 by simple randomisation. A computer random-number generator produced the allocation sequence. Women were assigned one by one until each group contained 11 participants. There was no blocking or stratification. Allocation was not concealed. Participants, therapists and assessors were not blinded.

1. Dry needling: needles 30 × 0.3 mm or 40 × 0.3 mm into palpated active trigger points of the anterior and posterior hip and thigh. Needling of a muscle stopped after two local twitch responses. Only muscles with active trigger points were needled.
2. Neuromuscular taping: both lower limbs, 0% tension on pre-stretched skin. Hip: fan of four to six tails, 5–8 mm wide, base proximal. Quadriceps, hamstrings and calf: Y-tapes 2 cm wide. About 30 seconds of light manual activation.
3. Kinesitherapy: about 60 minutes, with warm-up, Senior Fitness Test-based strength, endurance, flexibility and agility activity, then cool-down. The protocol both lists practice of the 2-minute step test and a high-knee progression from 30 seconds × 2 sets to 60 seconds × 3 sets. Delivered content was not independently verified.
4. Sequential combination: the same three components, each scheduled six times. Planned order in a session was dry needling, then taping, then kinesitherapy.

Six sessions over 4 weeks, about every 5 days, delivered by certified therapists. No untreated or sham group. Attendance and fidelity were not independently verified.
Intervention typeOther
Primary outcome measure(s)
  1. Quality of life measured using 18-item modified WHOQOL-BREF at baseline and 4 weeks
Key secondary outcome measure(s)
  1. Pain intensity measured using numerical rating scale at the hip, knee and ankle at baseline and 4 weeks
  2. Senior Fitness Test measured using chair stands, arm curls, 2-minute stepping in place scored as right-then-left pairs, flexibility and agility time at baseline and 4 weeks
  3. Functional independence measured using the Modified Barthel Index, nine domains, at baseline and 4 weeks
  4. Vital signs measured using peripheral oxygen saturation (SpO₂), systolic and diastolic blood pressure, and resting pulse at baseline and 4 weeks
  5. Body composition measured using bioelectrical impedance analysis (Tanita) of fat mass, fat-free mass, muscle mass, bone mass and body mass index at baseline and 4 weeks
Completion date07/02/2022

Eligibility

Participant type(s)
Age groupMixed
Lower age limit60 Years
Upper age limit120 Years
SexFemale
Target sample size at registration44
Total final enrolment44
Key inclusion criteria1. Women aged 60 years or older
2. Retired and community-dwelling
3. Members of the Centre for Healthy Ageing of the Municipality of Novo Sarajevo
4. Lower-limb pain for more than 3 months that affected daily activity
5. Written informed consent
Key exclusion criteriaSelf-reported physician diagnosis of osteoarthritis of a lower-extremity joint
Date of first enrolment07/01/2022
Date of final enrolment07/01/2022

Locations

Countries of recruitment

  • Bosnia and Herzegovina

Study participating centre

Centre for Healthy Ageing, Municipality of Novo Sarajevo
Azize Šaćirbegović 96
Sarajevo
71000
Bosnia and Herzegovina

Results and Publications

Individual participant data (IPD) Intention to shareNo

Editorial Notes

02/11/2026: Study's existence confirmed by the Ethics Committee of the Centre for Healthy Ageing, Municipality of Novo Sarajevo.